VIGORIS Medical Solutions

VIGORIS Medical Solutions

Germany Trade Sales no. 1

"Innovative medical products for a healthy life!"

Engineer Willi Hansel extends the VIGORIS Team

newsPosted by Office West Wed, March 30, 2016 11:04:40
Engineer Willi Hansel extends the VIGORIS team as a senior partner. Willi Hansel has decades of clinical experience.



With the further pursuit of Vigoris strategy as part of operator concepts, this step is conclusive. German hospitals increasingly have bottlenecks in the investment financing of movable assets. Therefore, operator concepts can represent promotional.

Willi Hansel will in future more involved in the business of hospital equipment. For details, refer our Healthcare News.

You can reach Willi Hansel as follows:

VIGORIS Office North
Am Weinberg 4A
38315 Schladen (Niedersachsen)

willi.hansel@vigoris-healthcare.de
+49160175 11 22
www.vigoris-healthcare.de

VIGORIS since 1996!

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PRE PURCHASE QUESTIONNAIRE (PPQ)

newsPosted by Office Nord-West Thu, February 04, 2016 13:31:29
Due to the growing demands in Germany and transparency for users, it has become necessary to have far-reaching transparency.

Also we needed this, some information based on the form.



The higher the transparency, the greater the confidence in the product by the end user.

www.vigoris-healthcare.de







  • Comments(0)//manufacturer.vigoris-healthcare.de/#post57

DECISION – Keep it simple an small.

newsPosted by Administrator Mon, December 22, 2014 21:34:03

From practice to practice.

We decide daily which innovative medical products, we assume in our sales program. We are often asked what decision calculus is applied here. We can explain this in great detail. But we do not want.

If you look at the film of University of Phoenix, you will understand the basis on which we make that decision.

http://youtu.be/f84LymEs67Y



www.vigoris-shop.com







  • Comments(0)//manufacturer.vigoris-healthcare.de/#post56

Mergers 2015 - Less health insurance!

newsPosted by Administrator Sun, December 21, 2014 11:59:55

The new health reform changed the health insurance industry sustainable. 2015, when the company health insurance fusion tendency reinforced to. This possibility will become even 125 health insurance companies.

The German BKK from Wolfsburg merged with BKK Essanelle in Dusseldorf and the German company health insurance, headquartered in Wolfsburg. The Esso BKK from Hamburg joins forces with the Novitas BKK from Duisburg. The shell BKK Life will go along with the DAK. The BKK Victoria goes to the BIG directly. The BKK Medicus joins forces with BKK VBU and the BKK BJB with BKK Gildemeister Seidensticker.

This development is already at the turn of fixed (assuming the supervisory authorities of the states or the Federal Insurance Office agrees). It can be assumed that during the year 2015, the concentration will increase.

www.vigoris-healthcare.de

  • Comments(0)//manufacturer.vigoris-healthcare.de/#post55

Health insurance in 2015 under pressure

newsPosted by Administrator Wed, December 17, 2014 18:54:37

Many public health insurance in Germany on 1.1.2015 reduce their contribution rates in effect. This makes it somewhat more favorable to the contribution rate payers in the coming years.

However, it should not be overlooked that the determination of the contribution rate of each individual health insurance is determined by the market here ("Strategic Price"). No health insurance company wants to be at the conversion date on 1.1.2015 expensive than the most direct competitors.

This can and will obtain individual health insurance in the coming year. The reserves of insurance are thereby used up what is wanted by law. But as the power output but so are about performance revenue, one way or another insurance provider will need to increase the contribution rate in 2015. This can lead to the relocation of the insured and cause a chain to the takeover by another health insurance.

Therefore it is expected that a strong influence will be made to the power output by the national health insurance. The largest output block are spending for inpatient care. Thus, the times for inpatient providers will inevitably harder. Many hospitals have no or only a few reserves. Therefore, here too the mergers and closures will continue to increase. In addition to the planned reform projects with the involvement of qualities as a result of increases and reductions to the MDK-tests are set to increase further.

A successful health insurance will continue on the one hand (to lose no insured) a competitive rate of contribution and better cost structures than the competitors must have health insurance on the other hand, in order to be successful in the market.

www.vigoris-healthcare.de



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Resource list of health insurance

newsPosted by Administrator Tue, December 09, 2014 13:39:55
Manufacturer beware of medical accessories!

In Germany you can only settle with the statutory health insurance if the medical device is registered in the resource directory under § 139 SGB V. The concerns in particular homecare products as capital or consumer goods for the patient. These currently include 40 product groups (main groups).

www.gesetze-im-internet.de/sgb_5/__139.html


An entry can be very beneficial for the distribution of medical aids. The doctor prescribe the medical device. Due to the general approval a statement in relation to the statutory health insurance can take place. In some cases, patient co-payments are up to 10% are possible.


https://hilfsmittel.gkv-spitzenverband.de/home.action

This requires a request of a manufacturer. Such a motion, the Association of Statutory Health Insurance has to decide within 3 months. For this purpose a communication has been adopted.

A request by a German distribution company by a supreme court ruling is not permitted. By repackaging and adding his own business name of the importer of a resource produced in other EU countries is not the manufacturer sense of § 139 SGB V (Bundessozialgericht B 3 KR 6/11 R)


www.gkv-spitzenverband.de

https://hilfsmittel.gkv-spitzenverband.de/hmvAnzeigen_input.action


Either a registration decision or a rejection notice stating the reasons. The medical services of health insurance is included in the process.



www.mds-ev.de/Antragsverfahren_Hersteller.htm


The entry is allowed but only manufacturers that support the development and production risk. Distributors are also not a manufacturer and does not qualify on their own behalf an application for entry in the resource directory under § 139 SGB V to make. This applies even if the distributor is working through its own labeling, repackaging, or the insertion of a German manual.

We are happy to assist manufacturers in the application process here.


www.vigoris-healthcare.de
info@vigoris-healthcare.de




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VIGORIS meets University of Landshut

newsPosted by Administrator Wed, December 03, 2014 11:41:02

VIGORIS HEALTHCARE MANAGEMENT has sales lecture at University of Landshut Economics graduate Dietmar Bönsch, VIGORIS partner keeps on December 15, 2014 at 17.30 clock within the network medical a lecture on sales of innovative medical products in Germany.

https://www.haw-landshut.de/aktuelles/veranstaltungen-termine/veranstaltungen-detailansicht.html?tx_cal_controller%5Bview%5D=event&tx_cal_controller%5Btype%5D=tx_cal_phpicalendar&tx_cal_controller%5Buid%5D=547&tx_cal_controller%5Blastview%5D=view-list%7Cpage_id-543%7Coffset-1&tx_cal_controller%5Byear%5D=2014&tx_cal_controller%5Bmonth%5D=12&tx_cal_controller%5Bday%5D=15&cHash=70670484fbde76b28c37b75dd277e818

In addition Dietmar Bönsch is also Professor Andrea Baduara, Faculty of Electrical Engineering and Industrial Engineering from the University of Landshut, presenting a paper on marketing strategies.

http://andreabadura.jimdo.com/lehre-haw-la/produktmanagement-techn-vertrieb/

Especially encouraging young medical technology companies and companies that develop a new business area of medical technology, are the focus of VIGORIS HEALTHCARE MANAGEMENT


www.vigoris-healthcare.de



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VIGORIS support start-ups

newsPosted by Administrator Wed, November 19, 2014 15:26:48

Ceremony on 12.12.2014 the runway Ruhr - Prices innovative companies in the medical industry are awarded - VIGORIS Healthcare Management Consulting donates prize of 1,500 EUR.


www.vigoris-healthcare.de





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52 million operations and medical procedures in hospitalized patients in 2013

newsPosted by Administrator Sat, October 25, 2014 14:16:49

early 52 million operations and medical procedures were performed at the in 2013 released from inpatient hospital care patients. The Federal Statistical Office further reported, were the 2.0% more than in 2012. It is, however, not take into account whether the increase is due to changes in the key operations- and procedure or to other reasons. The number of hospital cases in which an operation or medical procedure was performed during the same period by only 0.7% to 15 million. In each of these cases in 2013 were performed on average 3.5 measures.

Almost a third of the performed in 2013 measures were operations (15.8 million), followed by non-operative therapeutic measures with a share of 26.3% (13.7 million), diagnostic imaging with 19.7% (10.3 million ) and diagnostic measures with 19.2% (10 million). The remainder was spent on complementary measures such as birth concomitant treatments (1.9 million) and the administration of specific drugs (0.3 million).

Of the 15.8 million operations accounted for 41.9% to the 65-year-old patients. Among the most common operations in this age group included other operations on the intestine (for example loosening of adhesions or distention of intestine), endoscopic operations on the bile ducts and the implantation of an endoprosthesis of the hip.


Arthroscopic surgery on articular cartilage and the menisci play an important role, especially in the 45 to 64 year olds. Following in the rankings in this age group, followed by other operations on the bowel and the men of the closure of groin hernia in women.

In women aged 15-44 years were operations that are related to childbirth, most often. For men in this age group surgical procedures on the lower turbinate and arthroscopic surgery on articular cartilage and the menisci were made in the first place.

In children up to 14 years, the incision of the tympanic membrane at the opening of the tympanic cavity and the removal of the adenoids of the most common operations included.


www.destatis.de






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German healthcare Market

newsPosted by Administrator Sat, October 18, 2014 19:31:37

You are manufacturers of medical devices?

Take 10 minutes time and learn about the German health care market.


http://youtu.be/0rUu840QowA





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Medical device manufacturers test call

newsPosted by Administrator Thu, October 16, 2014 18:26:49
A medical device with a CE certificate for Europe to provide is the one to bring it in the German statutory health insurance billing, the other.

The Federal Joint Committee (G-BA) has taken innovation a new decision, which we would like to inform. 80% of the German population is covered by health insurance by law.

Because of a new legislative proposal is expected that the Federal Joint Committee (www.g-ba.de) will play increasingly important role in the financing of innovative medical products in the German healthcare system, outpatient and inpatient.

english
german (G-BA original)

www.vigoris-healthcare.de



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A topic for manufacturers?

newsPosted by Administrator Thu, October 16, 2014 09:45:23
Germans Federal Justice Minister Heiko Maas plans to submit a draft bill for a law against corruption in the health until December 2014. Such a law provides for the coalition agreement between the CDU and the SPD for the current 18th legislative period.

Maas' house has already organized in September 2014 with representatives of around 40 stakeholders a forum where various issues were discussed. Sure there was that bribery and corruption are to be found not only among physicians punishable. The penalty shall be based on the paragraphs 299 and 300 of the Criminal Code. This also means imprisonment.

Since not only the doctors will be affected alone, and manufacturers of medical devices and salesman of medical devices come more into focus.




www.vigoris-healthcare.de





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German Supply Support Act in work

newsPosted by Administrator Thu, October 16, 2014 09:09:23

Currently, the draft of the Supply Support Act before the competent federal ministries is tuned. The following rules there should be at level speakers:

Changes for patients

Soon, patients receive a schedule guarantee for specialist visits, should have a right to a second opinion before certain predictable operations and more freedom of choice in the selection of rehabilitation facilities.

Changes for outpatient and inpatient care providers

To draft bill also includes incentives for establishment of physicians in underserved and underdeveloped regions, promoting innovative forms of care as well as a development of provisions for participation of hospitals to outpatient care. Clinics and outpatient sector to better interlink Moreover, as the discharge management.

Changes for Medical Device Manufacturers

If related to highest risk classes II b and III as part of a financial arrangement to a new examination and treatment methods (NUB) are used, there should be a method for evaluating the method by the Federal Joint Committee.



www.vigoris-healthcare.de





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Lecture sales strategies for SMEs

newsPosted by Administrator Wed, October 15, 2014 18:02:08

http://www.medizin-technik-nrw.de/messe.php?mid=136



Information can be obtained Dietmar Bönsch under Mobil +49 176 54387699 or dietmar.boensch@vigoris-healthcare.de

www.vigoris-healthcare.de








  • Comments(0)//manufacturer.vigoris-healthcare.de/#post45

Current Company Flyer

newsPosted by Administrator Mon, September 29, 2014 15:10:23
https://docs.google.com/presentation/d/1ADvaILXclS6mRrKRkX-QZW5RR3-q0s9tjpH1tmbf7EI/pub?start=true&loop=true&delayms=3000





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Recommendations to users active medical devices

newsPosted by Administrator Sun, September 28, 2014 16:15:43

The complexity of medical devices has increased tremendously in recent years. Were the devices used to mechanically simple and autonomous, they are now increasingly controlled electronically and software support. Ultrasound machines, infusion pumps, ventilators, finding jobs are just a few examples. The more complex the product, the more likely it may occur with them specific risks when handling. Therefore, it is important for the user, particularly in hospitals to observe some basic rules:



ASSIGNMENT

Training of doctors and nurses in medical devices still represent a problem in hospitals. To the user of active medical devices in hospitals, we have the following recommendations Insist as a user that you are admitted to the rate applied by your medical equipment including software, either by the manufacturer for the authorized or instructed by the operator persons. Get introduced to document this. A replay of the briefing may possibly be necessary. The briefing is to (possibly training) convey not only the knowledge of purpose, determination of operability, proper handling, but especially over and out elsewhere risks inform the happened adverse events. This helps to ensure patient safety and reduce liability risks.

FUNCTIONAL TEST

The functional testing of the medical device should be done carefully. Have a look on the application of a medical product of its functionality and odnungsgemäßen state. A checklist can facilitate this. Sometimes it is useful to pass this exam to document short.

ERROR

Errors and problems should always be reported. If in doubt, report events to the clinic of internal reporting. The more detailed your information to the participating medical products, the more likely affected devices can be identifed by the medical, checked and replaced if necessary and ensured. The colleagues from the reporting system can easily recognize whether medicine associated risks involved. Messages are then passed on to the Vigilanzbehörde.

The user of a medical device must be required for the application training or knowledge and experience have. He must a medical device each apply only after verifying the proper condition and functioning. In incidents of users of legal reporting obligation is subject to a measure of preventive security
(http://www.bfarm.de/DE/Medizinprodukte/_node.html).


www.vigoris-healthcare.de







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Our experience for you!

newsPosted by Administrator Sun, September 28, 2014 11:48:52
www.vigoris-healthcare.de

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Business Plan Competition

newsPosted by Administrator Fri, September 26, 2014 21:43:29
Young companies in the medical technology industry in North Rhine-Westphalia are called the Business Competition medicine industry to participate (http://startbahn-ruhr.de/businessplan-competitive-medical industry). As part of the competition is the deadline for the detailed business plans in late October 2014th.


Economics graduate Dietmar Bönsch, partner of VIGORIS HEALTHCARE MANAGEMENT, has been invited by the Medical NRW and Ruhr MedEcon to keep mid-October as part of the preparation of the business plan a lecture "sales strategies for the medical industry" in Essen.

For economics graduate Dietmar Bönsch is a major issue that the distribution is a prerequisite for sales planning. Very few medical device manufacturers have concrete idea of the German health care system, which is very regimented and many institutional players play a role before a product can be sold successfully in Germany.

We are pleased to support young companies in the medical technology industry in the Ruhr area (North Rhine-Westphalia).

www.vigoris-healthcare.de

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Network meetings with VIGORIS

newsPosted by Administrator Thu, September 25, 2014 21:30:34

Vigoris Healthcare attended the University of Landshut at the network meeting of medical technology. This should be an intensive exchange between science, industry and end users. This is also done. What is striking, however, again, is the fact that medical technology companies do have good business ideas that have already been implemented, but do not think about the distribution of their ideas and products.

However, this can have fatal consequences, if indeed good products have emerged, but lack of knowledge of the regulations of the German health care sales and so have sales problems.

www.vigoris-healthcare.de





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Alternativen zur medikamentösen Fixierung

newsPosted by Administrator Mon, September 15, 2014 16:02:54

Verbesserung der Versorgung dementer Patienten auf den Krankenhausstationen mittels inPulser-Schlaftherapie?

(Improving care of demented patients on the hospital wards by inPulser sleep therapy?)

Ja, durch die inPulser-Schlaftherapie können direkte und medikamentöse Fixierungen von unruhigen und dementen Patienten reduziert bzw. vermieden werden.

(Yes, by inPulser sleep therapy drug fixation or direct fixation of unstable and demented patients can be reduced.)

Einzelheiten sind der angefügten Datei zu entnehmen.

(Details are given in the attached file.)

deutsch

(english-short)


www.vigoris-healthcare.de




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Hospital market exits in Germany 2003-2013

newsPosted by Administrator Fri, September 12, 2014 17:14:13

In the entire study period, especially small hospitals closed (average 70 beds) were. The evaluation of the hospital market exits by types of settlements shows that about 70% of all market outlets in urban districts and cities and rural districts have taken place with compression approaches. Only about a quarter of all market outlets covered sparsely populated rural counties.

http://www.gkv-spitzenverband.de/krankenversicherung/krankenhaeuser/gutachten_marktaustritte_krankenhaeuser.jsp

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Basic rule in sales with hospitals!

newsPosted by Administrator Thu, September 11, 2014 11:12:30

The german hospital buyers has researched and selected a supplier who has supposedly exactly the product or service that needs to be hospitalized. Now the hospital buyer wants to know if the offer of this supplier covers your specific requirements.

The hospital buyer shall contact the seller to contact. This will send its seller. The specialist. The person who tells you exactly how the product or service can help you in your business.

If it turns out that the seller does not know more about the product, as he have hospital buyers themselves, and much less expected over the health care industry as you - what is the result? The hospital buyer does not trust the sales staff, its medical device and his company. A sale does not take place.

The first visit will decide whether a hospital is taking the next step with a potential supplier. This decision is based on trust. The seller who gains the trust of the hospital purchaser gets the chance in the sales process continues to progress and get the job. Trust wins the seller, the knowledge imparted and understood the health sector as well as the purchasing business of the customer.

On the subject of industry knowledge complained a disgruntled hospital buyer: "It makes me crazy, constantly educate retailers about our business."

VIGORIS Health Care Management employs only experienced salespeople. Without this a successful sales in b2b business with hospitals and doctors is hardly possible.


www.vigoris-healthcare.de



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Newsflasch SHI

newsPosted by Administrator Thu, September 11, 2014 10:45:51

The statutory health insurance (SHI) in germany has the first half of 2014 completed with negative results. This is evident from the latest statistics of the Federal Ministry of Health (BMG) out. Thereafter, the shortfall is approximately 630 million euros on revenues of about 101.7 billion euros and Expenditure of 102.3 billion euros.

Market assessement: The pressure of the health insurance to care providers, the pharmaceutical industry and manufacturers in 2015 will grow stronger.

In addition to high product quality, the economic factors are getting an increasing importance. Manufacturers of medical devices, pharmaceuticals and biotech companies should take this into account in their pricing and distribution plans for the German market.

www.vigoris-healthcare.de

  • Comments(0)//manufacturer.vigoris-healthcare.de/#post36

Asked German market knowledge

newsPosted by Administrator Thu, September 11, 2014 10:25:43

The significant change in the German hospital landscape will have a significant impact on the distribution of medical devices in the b2b business. Not the clinics can only be illiquid, particularly through mergers and closures, specializations the market is getting tougher by the distribution of medical devices in Germany.

European manufacturers often know not the specialty of the German health care market. With few resources you would like to expand sales on the German market. Of course! But not very productive! Sales approaches are often "technically oriented". Here, the european medical companies want to sell. Although there are also asked technician, but mainly it depends on the specific knowledge of the German health system and there acting potential buyers to. Who does not have this knowledge, will not be able to enter the German health care market, or have to pay a lot of dues.

VIGORIS Healthcare Management consultancy support, but especially through the acquisition of sales activity in the so called b2b business to hospitals, doctors' offices, support groups, health insurance, nursing homes and care services.

We have the know how and the contacts and organize successful distribution and marketing, so that your sales figures are right.

Let her sell medical device successfully with us!


www.vigoris-healthcare.de



  • Comments(0)//manufacturer.vigoris-healthcare.de/#post35

Vigoris meets EFRE launch event

newsPosted by Administrator Thu, September 04, 2014 19:28:10

EFRE.NRW investment in growth and jobs-Innovative health projects are funded, starting in February 2015!

Today, the opening event of the funding of the European Union for the region North Rhine-Westphalia. In eight defined key markets, which also includes the lead market health, they may apply.

VIGORIS Healthcare was exclusively invited to the opening event. Also detailed discussions with representatives of the state NRW in of the European Union as well as with representatives of the Cluster Management MedizinTechnik NRW could be performed.

In particular, the special issues from manufacturers innovative medical technology with a view of the statutory health insurance had to be discussed at the edge of the event, said Dietmar Bönsch, VIGORIS partners.

www.vigoris-healthcare.de



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Vigoris takes another exclusive sales

newsPosted by Administrator Thu, September 04, 2014 19:24:31
Innovative companies in the healthcare industry are in high demand at VIGORIS Healthcare. This both in business consulting as well as in commercial distribution of innovative medical devices.

On September 3, 2014 was between Infra Sonics, on the Inpulser in the frame has a patent and CE approval sleeping therapeutic indications, and VIGORIS Medical Solutions an exclusive distribution agreement in B2B - Sales at hospitals, clinics, medical care centers, support groups, nursing homes and - services or payers are completed.



Image: Dietmar Bönsch, VIGORIS, left, and Jerome Lavrut, INFRA SONICS at the contract signing on September 3, 2014 in Cologne

Dietmar Bönsch and Rüdiger Müller, both VIGORIS partners, are delighted, not only from the health care providers (including hospitals, clinics) or the German biotechnology industry, but also from the producing medical industry from Germany to have won as mandates. Just the designated special expertise and the network of VIGORIS Health Care in the German health was a decision criterion of Infra Sonics for the long-term partnership agreement. For Rüdiger Müller is clear that VIGORIS HealthCare his special mission and high standards in the German health care system will continue to meet as a special partner.

The Inpulser sleep therapy is for insomnia is a very good form of therapy. ENTs and sleep medicine oriented internists get so a new, innovative therapy instrument under the inpatient, day-patient or out-patient treatment at the hand.

But also in the application area hospitals and nursing homes for patients with dementia, an acute care clinic located, the use of Inpulsers for Nursing or in use, in residential care homes be represented as a very care-relieving. Ill just ask people with dementia in nursing staff in hospitals and homes increasingly facing new challenges. We are therefore very happy to have one another such innovative medical product in our sales portfolio in the German healthcare market, so Bönsch. The care must be helped with your hard work on the wards in the care of demented patients. Since the Inpulser can offer you good support.

Details of the innovative sleep medicine therapy of Inpulser can be taken:

http://www.inpulser.de/en


  • Comments(0)//manufacturer.vigoris-healthcare.de/#post33

Updated medical aids catalog

newsPosted by Administrator Fri, August 29, 2014 18:21:42

In the German auxiliaries catalog after 139 SGB V and nursing aids catalog after 78 SGB XI over 20,000 medical products are now listed.

With notices of August 18, 2014 other products were added. These can be found in the Appendix.


www.vigoris-healthcare.de



  • Comments(0)//manufacturer.vigoris-healthcare.de/#post32

VIGORIS - excellent sales skills

newsPosted by Administrator Sat, August 23, 2014 15:04:33

http://www.harvardbusinessmanager.de/blogs/warum-die-verkaeufer-schlechter-werden-a-984908.html

B2B sellers are bad, according to the Harvard study. The cause is seen in inadequate product and industry knowledge.

VIGORIS Medical Solutions has extensive experience in the German healthcare since 1996. We know from excellent in the indications, the products and the health care industry.



  • Comments(0)//manufacturer.vigoris-healthcare.de/#post31

Network Medical University of Landshut

newsPosted by Administrator Wed, August 20, 2014 11:09:45
VIGORIS Healthcare Management takes on 18 September 2014 at the invitation of the University of Landshut (Bavaria) on network medical part.

In particular, the improvement of doctor-patient communication with interactive visual aids (Ambient Assisted Living) is in the foreground.

To learn more about our event participation, then please contact us.




www.vigoris-healthcare.de


Are you interested in a sales cooperation. About the link to go directly to our contact form.

http://vigoris.wls.net/





  • Comments(0)//manufacturer.vigoris-healthcare.de/#post30

EU funding of NRW

newsPosted by Administrator Wed, August 20, 2014 10:49:35

North Rhine-Westphalia (NRW) is concentrated in the funding period 2014-2020 the European Regional Development Fund (ERDF) to focus innovation, SMEs, climate and communities. A total of about 2.4 billion euros by 2020 are available, half of which is provided from the EU budget. They represent all regions of the country are available and are distributed primarily through competitions.

VIGORIS Healthcare Management was invited to the launch event on September 4, 2014 of the Ministry in Dusseldorf for NRW-EU program under the direction of Minister Garrelt Duin. The program "Investing in growth and jobs" also provides funding for the medical technology industry.

To learn more about our event participation, then please contact us.




www.vigoris-healthcare.de

Are you interested in a sales cooperation. About the link to go directly to our contact form.

http://vigoris.wls.net/



  • Comments(0)//manufacturer.vigoris-healthcare.de/#post29

BioTech - VIGORIS supports German market

newsPosted by Administrator Sun, July 06, 2014 11:25:38

VIGORIS Healthcare Management has received an order for an international biotech company to the conceptual support in the German market.

VIGORIS Healthcare Management specializes in the launch of EU-approved medical devices in Germany.




www.vigoris-healthcare.de

http://vigoris.wls.net/



  • Comments(0)//manufacturer.vigoris-healthcare.de/#post28

Aid list the statutory health insurance

demand forecastPosted by Administrator Sun, June 22, 2014 15:02:03

The central association of statutory health insurance in Germany created a systematically structured resource directory annually. It is intended to provide a comprehensive product transparency for insured health care provider, contract physicians and health insurance and lists can be prescribed aids at the expense of public health insurance on.

The resource directory is organized by product group. Each product group is systematic in application places divided subgroups / quality standards and product types / indications. As classification criterion the position number is used. Specific quality requirements for aids can be set there as well. The inclusion of a resource is at the manufacturer's request. The resource directory is updated regularly, that is the system and the quality requirements, which is further developed or changed, new products or products deleted. The resource directory will be published in the Federal Gazette.

This is based on § 139 SGB V (Krankenversicherung), § 78 SGB XI (Pflegeversicherung)


In the list included tools are listed by the obligation of the health and care funds. In addition to a detailed requirement specification and the listed manufacturers of the products of tools are listed.

Link to the aid list:

https://hilfsmittel.gkv-spitzenverband.de/hmvAnzeigen_input.action


If you are producing a medical device in Europe and not listed in the resource catalog of the statutory health insurance funds in Germany, then please contact us. We can help you!


---------------------------------------------------------------------------------------------------------

***legislative text § 139 SGB V (Krankenversicherung)***

(1) The Central Federal Association of Health Insurance created a systematically structured resource directory. In the list included from the performance obligation aids are listed. The resource directory is to be announced in the Federal Gazette.

(2) To the extent necessary to ensure an adequate, expedient and economical supply can be set in the resource directory indication-based or case-specific quality requirements for aid. Specific quality requirements, by Theorem 1 can also be set to allow a sufficiently long useful life, or in appropriate cases, the re-use of aids other insured. In the resource directory, the requirements can be controlled in addition to the services to be provided for the provision of auxiliary services.

(3) The inclusion of a resource in the resource directory is at the manufacturer's request. Decides on the admission of the Central Federal Association of Health Insurance; he may have an audit of the medical service, whether the conditions referred to in paragraph 4 are met.

(4) The tool shall be included if the company stated performance and safety, the fulfillment of the quality requirements referred to in paragraph 2 and, where required, detected the medical benefits and it is provided with the information necessary for the proper and safe handling in German language .

(5) For medical devices within the meaning of § 3 No. 1 of the Medical Devices Act of proof of functional suitability and security through the CE marking is generally considered provided. The Central Federal Association of Health Insurance satisfy itself of the formal legality of the CE marking on the basis of the declaration of conformity and, where applicable, the certificates involved in the conformity assessment notified body. Reasonable grounds to additional checks can be made and required for this purpose will only be requested. Exams by Theorem 3 can also be made on the basis of samples after receiving the product. If, during the exams by Theorem 2 to 4 evidence that provisions of the medical devices legislation are not observed, other consequences are without prejudice to inform the competent authorities thereof thereafter.

(6) Where the manufacturer prior incomplete application documents is a reasonable time, which shall not exceed six months in total, giving the missing documents. If not fully available after the deadline required for the decision on the application documents, the request is rejected. Otherwise, the Central Federal Association of Sickness Funds, within three months after submission of all documents. About the decision, a decision shall be granted. The recording shall be revoked if the requirements of paragraph 4 are no longer met.

(7) The procedure for holding tools in the tools directory regulates the Central Federal Association of Health Insurance in accordance with paragraphs 3 to 6 He can provide that is assumed to compliance with requirements, provided test certificates of appropriate institutions are presented, or the compliance with relevant norms or standards is demonstrated in an appropriate manner.

(8) The resource directory is periodically reviewed. The update includes the development and changes of the system and the requirements of paragraph 2, the addition of new tools and the deletion of products, was withdrawn their inclusion or revoked pursuant to paragraph 6, sentence 5. Prior to development and changes in the system and the requirements of paragraph 2 the umbrella organizations of the concerned manufacturer and service provider is and provide the necessary information within a reasonable time for this opportunity to comment on; the comments are to be included in the decision.



***legislative text § 78 SGB XI (Pflegeversicherung)***

(1) The Central Federal Association of the care funds closes with the service providers or their associations to contracts for the supply of insured care equipment, provided these are not to be compensated according to the provisions of the Fifth Book of the tools. Notwithstanding sentence 1, the care funds may enter into contracts for the supply of insured care equipment in order to take more into account the efficiency principle. The § § 36, 126 and 127 of the Fifth Book shall apply accordingly.

(2) The Central Federal Association of the care funds created as an attachment to the resource directory under § 139 of the Fifth Book a systematically structured care resource directory. It sets out the covered by the obligation of long-term care nursing assistants, to the extent not already included in the resource directory. Care aids that are suitable for loaning to the insured shall be shown separately. In addition, § 139 of the Fifth Book shall apply mutatis mutandis with the proviso that the associations of nursing and of disabled people are to be consulted before setting up and monitoring of care tools directory also.

(3) The national associations of care funds agree that the more appropriate to borrow the purpose referred to in paragraph 2, sentence 4 nursing aids, including their procurement, storage, maintenance and control each other or with a suitable care facilities. The patient and the licensed care facilities shall be informed of the care funds or their associations in an appropriate manner of the Loan option.

(4) The Federal Ministry of Health is hereby authorized to determine the nursing aid list referred to in paragraph 2 and the fixed amounts referred to in paragraph 3, by ordinance, in agreement with the Federal Ministry of Labour and Social Affairs and the Federal Ministry for Family Affairs, Senior Citizens, Women and Youth and with consent of the Bundesrat ; § 40 para 5 shall remain unaffected.


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Statutory health insurance mobilize against CE approval!

demand forecastPosted by Administrator Sun, June 22, 2014 14:28:04

Make the statutory health insurance funds with a position paper mobilize against the current approval process of medical devices in European Union (CE marking). The position paper calls for a significant tightening of the eligibility criteria modeled after the United States. Currently tested and certified in Europe so-called private "Notified bodies" such as the TÜV high-risk medical devices for the European market. At the end of this process gets this high-risk medical device called the CE marking, as it get about and electric household appliances. Throughout Europe there are approximately 80 of the Notified bodies may award the CE seal for high-risk medical devices. medical device manufacturers are free to choose in which of these private institutions, they can test their product.

In the United States is taking over the Food and Drug Administration (FDA) issued a public authority the assessment and approval of such high-risk medical devices. Unlike in Europe, clinical trials are an integral part of the procedure and necessary condition for the admission of these sensitive products.

From the perspective of the statutory health insurance funds the result: While many medical devices may be initially marketed in Europe had to be withdrawn for safety reasons but later, reached the same products in the U.S., not even on the market. For example, the American product Robodoc was never approved in the U.S. for general use in the clinic operation, but was in Germany to inspection by TÜV Rheinland Europe-wide approval.




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AOK - New drugs contracts for 2014/2015

demand forecastPosted by Administrator Sun, June 22, 2014 13:58:10

The AOK community (Germany's largest health insurance company Legal) in early June 2014 granted the surcharges for the 13th installment of the nationwide drug discount agreements. There were 27 pharmaceutical companies closed 504 contracts for 56 active ingredients and combinations. The new installment contract runs from 1 October 2014 to 30 September 2016.'s Annual AOK sales volume with the medicinal products concerned stood at around 1.1 billion euros.

To the active ingredients of the 13th installment includes the particularly strong sales preparations metformin to treat diabetes, blood pressure medicine metoprolol and the antipsychotic olanzapine.

Currently, the AOK community 248 generic drugs / generic combinations with an annual sales volume AOK (pharmacy retail price) of a total of around five billion euros under contract. From October there are then 260 agents / combinations. Due to the nationwide discount agreements the AOK community could save more than 3.6 billion euros in spending on drugs since 2007, despite a consistently high quality of care.



An overview of the contracting parties, the application areas and the respective drugs or drug combinations can be obtained on request from us.


As part of the budget negotiations of hospitals these discounts also play an important role if the hospital additional charges shall be agreed on medicinal active compounds by the KHEntG (Krankenhausentgeltgesetz) with the statutory health insurance. In addition to the reduced purchase prices and smaller quantities purchased for the additional charges play a role, not all packs are agreed.


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CHIR-NET: innovative processes and products

newsPosted by Administrator Thu, June 19, 2014 15:16:40

The german CHIR-Net is germany's largest study network for surgical studies and consists of eight regional Centers (Berlin, München, Mainz, Marburg, Witten/Herdecke, Göttingen, Heidelberg und Lübeck/Kiel). The common goal is the patient-centered surgical research to examine operational procedures through clinical trials and so to find better treatment options for all patients. It has been found that the entire medical treatment by participating in a clinical study is significantly improved. In addition to access to new procedures, medicines and medical devices, study participants will benefit from the improved care by specially trained study physicians and study nurses. The German CHIR-Net provides a professional infrastructure for surgical trials. In addition to the performance of surgical studies, this includes the establishment and further development of quality assurance, study methodology and training in surgical studies.

The goal is to bring effective therapies based on scientific results quickly in the clinical care, so as to enable each patient a better Treatment.

Especially for medical device companies can access to CHIR-NET for new processes and products to be important.

Links to the eight CHIR-Net regional Centers:

http://www.chir-net-muenchen.de

http://www.sdgc.de

http://www.chirurgie-goettingen.de

http://www.ukgm.de/ugm_2/deu/umr_ach/index.html

http://crzberlin.charite.de

http://www.chirurgie.uni-luebeck.de/patienten/chirurgische-forschung/chirurgisches-netzwerk-chir-net.html

http://www.izks-mainz.de/22-0-Chirurgisches-Netzwerk.html

http://www.uni-wh.de/gesundheit/institut-forschung-operative-medizin-ifom/forschung/zksi/





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innovations must be paid, or not?

demand forecastPosted by Administrator Wed, June 18, 2014 17:28:44

A combination product of medical technology and pharmaceuticals are drug-coated stents. In the past, this new examination and treatment methods (Nubs) were refinanced through cardiac DRGs addition at the clinics.

Since the health insurance but have to abide by the guidelines and policies of the Federal Joint Committee, Refinancing with Nubs as a special operating expenses fee will be increasingly difficult. Hospitals that use these coated stents, therefore have to expect reductions in sales.

This development is also not a happy development for the manufacturer of this combination product in the statutory health insurance. Therefore, it is important that the health insurance or corresponding SGB V - experts are involved early in the development of innovative medical devices.

It would be a shame to the years of development costs (including financial aid by funding authorities of the federal or state)!

https://www.g-ba.de/informationen/beschluesse/1681/

http://www.dkgev.de/dkg.php/cat/64/aid/10621/start/30/title/Gemeinsamer_Bundesausschuss_-_Leistungsausschluss_nach___137c_SGB_V


Bildquelle: http://img.medicalexpo.de/images_me/photo-g/antikorperbeschichtete-koronarstents-edelstahl-78181-7075259.jpg



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KMU biotech bavaria

newsPosted by Administrator Wed, June 18, 2014 16:58:08


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medical technology cluster bavaria

newsPosted by Administrator Wed, June 18, 2014 15:43:05



The graph below gives an overview of the medical technology cluster in Bavaria. The size of the squares represents here the number of settled in this region medical technology manufacturers.

Economic data (Bavaria) from the year 2013 can be obtained from the following files.


http://www.medical-valley-emn.de/

http://www.igz.wuerzburg.de/igz/zentrum/index.html

http://www.izb-online.de/

http://www.bioregio-regensburg.de/





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Impressum

ImpressumPosted by Administrator Tue, June 17, 2014 14:24:40
IMPRESSUM

Anbieter dieser Website im Sinne des Telemediengesetzes (TMG) und inhaltlich Verantwortlicher gemäß § 55 Abs. 2 RStV:

Diplom-Ökonom Dietmar Bönsch
Postanschrift:
V I G O R I S Healthcare Management Group
Plauener Straße 5
84036 Landshut
Deutschland

www.vigoris-healthcare.de

info(at)vigoris-healthcare.de

Für alle Links auf diesem Blog gilt, dass wir keinerlei Einfluss auf die Gestaltung und die Inhalte der verlinkten Websites haben. Wir übernehmen somit keinerlei Verantwortung für Inhalt und Gestaltung dieser Websites.

URHEBERRECHTE

Alle Elemente sind – sofern nicht ein anderes Copyright angegeben ist – für die V I G O R I S Healthcare Management Group bzw. Diplom-Ökonom Dietmar Bönsch urheberrechtlich geschützt. Jede Verwertung außerhalb der engen Grenzen des Urheberrechtsgesetzes ist ohne die Zustimmung von V I G O R I S Healthcare bzw. von Diplom-Ökonom Dietmar Bönsch unzulässig und strafbar. Dies gilt ohne vorherige schriftliche Erlaubnis nicht für Fotos und Karikaturen, die grundsätzlich urheberrechtlich geschützt sind



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sales development of the german medical manufacturer

newsPosted by Bönsch Dietmar Wed, June 11, 2014 21:54:53

stagnant domestic sales, foreign sales to rise, exports account for 65 percent

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german code of medical products for manufacturers and distributors

newsPosted by Bönsch Dietmar Wed, June 11, 2014 20:26:32
http://www.medtech-kompass.de/downloads-detailansicht/items/kodex-medizinprodukte.html

The german code of medical products for manufacturers and distribution is made in many contracts of sale of medical devices for part of the contractual relationships.

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portal of the industry of the German economy

newsPosted by Bönsch Dietmar Wed, June 11, 2014 19:40:17
Aids to replace failed or impaired body functions, facilitate, complete or settled. This includes prostheses (dentures), support appliances (orthoses) and orthopedic shoes. Other aids are hearing aids, wheelchairs, but also provides guidance for blind people, etc.

In the german public health insurance is a basic entitlement, which also includes modification, repair, replacement and training in the use and necessary for the protection of the insured maintenance and inspections.

www.rehadat-hilfsmittel.de


Legal co-payments - § 33 paragraph 8 in conjunction with § 61 sentence 1 SGB V: co-payments that have to pay insured amount to ten percent of the selling price, but at least five euros and a maximum of ten euros; but not more than the cost of the composition. The co-payments apply only after completion of the 18th year. For tools, a distinction is intended for consumption and not intended for consumption aids. To use certain tools - § 33 paragraph 8, clause 3 of the SGB V: The co-payment for certain aids for consumption is 10 per cent of the receiving total by the insurance company to amount to a maximum of 10 Euro for the whole month's supply.

intended for consumption aids = only once continuous use possible

Month's supply = calendar month. Need insured on the basis of several different diseases intended for consumption aids, the co-payments for the delivered tools are independent of the number of service areas be paid only once.



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MT imports - additional conformity assessment procedures

newsPosted by Bönsch Dietmar Wed, June 11, 2014 13:49:32

Parallel imports of medical devices belongs in an era of globalized markets everyday business, but holds some legal stumbling block ready. Armed gestation is primarily the constellation that a medical device is imported without or against the will of the manufacturer for the German market. But even if consensual interaction of German importer and foreign manufacturers to open up legal pitfalls with which both might not expect. Thus, the German importer can suddenly mutate into a manufacturer of a legal sense "new" medical device - with all the manufacturer's legal obligations - such as a recent decision of the Bundesgerichtshof (BGH, judgment of 12.05.2010, I ZR 185/07) occupied. The decision of the Supreme Court concerned a situation in which a company, an in vitro diagnostic device that was brought from producers in other Member States of the EU market, imported to Germany, the outer packaging with a German label knew it, the package after opening a German-speaking Instructions were annexed and brought the so repackaged products on the market. A separate conformity assessment did not lead by the German importer. This kept the Supreme Court to be inadmissible. Anyway, in vitro diagnostic medical devices for self-testing, the court may be marketed in Germany only on the market if they contain an instruction manual and a single label in German language, which have been previously reviewed in a new or additional conformity assessment procedures. Although the parallel imported product disposal in the specific case of a CE mark, which was a project carried out in the Netherlands conformity assessment proceedings. After importing to Germany but was re or complementary conformity assessment procedures carried out, because the importer, the original presentation of the product by amending by he knew the carton with a German label and package were annexed a German-language instruction manual. A company that has been put into by the manufacturer in a Member State of the European Economic Area in traffic medicine product that is provided by a conformity assessment procedure with a CE marking, imported to Germany is in principle not obliged to carry out a new conformity assessment procedures for this product if it wanted to sell the product into Germany unchanged. By repackaging and enclosing a German instruction manual but a new medical device within the meaning of § 3 No. 1 and 4 MPG being manufactured. The sales of the repackaged parallel imported product thus constitutes a first-time market a from the originally marketed abroad distinctive in vitro diagnostic medical device for self-testing dar. Although this decision of the Supreme Court directly affects only in-vitro diagnostic medical devices for self-testing. The decision may hardly seem impossible but that these principles could be applied to other medical products. In the parallel import of medical devices - whether it be with the consent of the manufacturer, be it past this - special care should be exercised to avoid being unintentionally by the dealer to the manufacturer of a medical device.

Deutsche Medizinprodukte Verordnung: www.gesetze-im-internet.de/mpv_2002/

Urteil v. 27.6.13 - 6 U 253/11: www.openjur.de/u/682494.html

Übersicht benannte Stellen in Europa: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.main



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Rückblick: Vigoris meets MT Cluster NRW

newsPosted by Bönsch Dietmar Tue, June 10, 2014 16:57:32


Rückblick und kleines Fazit


Auf dem Innovationskongress am 11. Juni der Landesregierung NRW wurde unter anderem über die Bedeutung eines schnelleren Zugangs von Patienten und Kliniken zu medizinischen bzw. medizintechnischen Innovationen gesprochen. Dabei geht es sowohl um Systeminnovationen, die über die Sektorengrenzen hinweg Anwendung finden können als auch um (personalisierbare) Produktinnovationen, die eine höhere Behandlungsqualität versprechen.

Spezialisten und Fachleute mit weitreichenden praktischen Erfahrungen wie VIGORIS HEALTHCARE MANAGEMENT können "eine Brücke und Schnittstelle" zwischen den Leistungserbringern (Healthcare Services) der unterschiedlichen Sektoren und der medizin-technischen Industrie gestalten.



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innovations develop

newsPosted by Bönsch Dietmar Mon, June 09, 2014 16:42:40

Innovation of new medical devices develop at the intersection of medical technology, biotechnology and pharmaceutical industries. The Medical receives a biologisation such as by means of coatings of implants, regenerative medicine, and the use of biological materials. More and more medical devices are formed as combination products with drugs such as Drug coated stunts, coated with an antibiotic bone cement displaced or heparin catheter. The pharmaceutical and biotechnology industries provide bioengineered ago pharmaceuticals, biomarkers or Companion diagnostics. Especially in the combinations of pharmaceutical, biotechnology and medical technology may arise far-reaching innovations.


However, it must not be overlooked that institutions such as the Federal Joint Committee reviewed the innovative products compared to otherwise process. Just drug coated stunts have experienced since 2013 limitations in the application by operational methods has been given priority in the application.

https://www.bundesanzeiger.de/ebanzwww/wexsservlet?session.sessionid=4adeafa093208bda5fe91da48d0083a6&page.navid=detailsearchlisttodetailsearchdetail&fts_search_list.selected=71db9cbfe0306eb9&fts_search_list.destHistoryId=95055



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Logistics through sensor networks

newsPosted by Bönsch Dietmar Sun, June 08, 2014 12:35:49

In the hospitals diverse logistics processes are initiated. Materials, tools, equipment, and patients must be varied moves.

About Sensor Networks objects can communicate and collaborate with each other in a network. The Fraunhofer Institute has developed here, the S-Net technology. About the project Opal Health Resources and inventory for the purposes of an optimized device management can be managed with low seek times, safety stocks and thus costs. The Opal Project Pat locating patients, the patient pathway and waiting times at the center.

Both approaches are very interesting for the clinics, since an optimal treatment chain not only the quality can be increased, costs may also be reduced through reduced lengths of stay. When resources, such as an ultrasonic equipment is available at all times, the number of purchase of such equipment and thus costs for maintenance, servicing, Med-GM and tests can be reduced. The hospital staff must be less scanning of devices.

In contrast to traditional technology, the S-Net sensor networks can communicate actively and bi-directional. Activating by a reader is not required.



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3D printers - new perspectives

newsPosted by Bönsch Dietmar Sun, June 08, 2014 11:59:43

3D printers are all the rage. Many can imagine little here below but. Especially in medicine, these printers future prospects in the generative production of products or the customer individual production. What does that mean?

People are not all the same. Today standard products are prefabricated analogous to the clothes for people. It is also the case of medical products, such as with artificial joints (knee / hip), artificial bone or even heart valves (developed at the German Heart Institute in Berlin). Standard production processes here are the metal lasers, metal casting, followed by milling or injection molding. These have their limitations but especially in complex structures and cavities or need to be assembled. The principle of the 3D printer works like this: The raw material is as a powder. Layer by layer, it is borne in a printing machine and placed in a three-dimensional shape. In this way, structures can be created quickly and easily, where other technologies are facing serious problems - such as cavities or seamless steel hinges.

Just hearing aids that adapt to your ear canal, templates for setting knee prostheses, orthoses, surgical plates and splints or dental prostheses can be made through the 3D print. Already, research is being conducted together with biomaterials used in applying 3D printer in organ regeneration and organ replacement.

Doctors at the University of Michigan saved a little boy with a tracheal stent from the 3D printer life. However, this must not obscure the fact that the application in medicine is still in its infancy. The 3D print will find in the coming years its applications in medicine and medical technology.

With regard to the uses of materials, the cost per qm3 pressure, rapid transfer of CAD files or the speed but overall, particularly in the areas of application for components with complex geometries or structures that do not conventionally can be produced, the future lies. Especially with 3DPrint to be used in the body, the rejection properties are to be clarified.



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Vigoris meets MedTEC 3.-5- Juni 2014

newsPosted by Bönsch Dietmar Wed, May 14, 2014 12:30:24
www.medteceurope.com


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medical devices - link to statutory provisions

newsPosted by Bönsch Dietmar Mon, May 12, 2014 22:20:45
http://www.dimdi.de/static/de/mpg/recht/index.htm

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the appropriate conformity assessment procedure

newsPosted by Bönsch Dietmar Mon, May 12, 2014 14:59:36

Medical devices are classified in function of light emanating from you risk potential in different product classes. So it is understandable that from a unsafe framed Association is generally less danger to the patient or others emanates from an insecure than about framed ventilator.

1. Required classification of medical devices

In Annex IX of Directive 93/42/EEC to find definitions for the classification rules for medical devices. These representations are primarily directed at manufacturers who divide based on the 18 rules of Annex IX to their medical product in the appropriate class. This classification rules based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices , see recital 14 of the Directive.

On the basis of the classification rules of Annex IX to Directive Medical devices are classified in correspondence to their hazard potential in four classes. There are classes I , IIa , IIb and III .

Class I medical devices with a low degree of hazard (eg, wheelchairs , servants , associations, glasses)

Classes IIa and IIb with moderate or increased hazard potential (eg hearing aids, disinfection products , contact lenses, x-ray equipment )

Class III high-risk , such as artificial heart valves.

The European Union has issued guidelines for the classification of facilitating the necessary classification . This " MEDDEV Guidelines for the classification of medical devices" are available in English at the following link .

For the different product classes , different conformity assessment procedures to be used. The correct classification of the medical device thus has a decisive influence on the selection of the appropriate conformity assessment procedure , which has to go through the respective medical product to bear the CE marking must also .

2. The different conformity assessment procedures

The manufacturer is responsible for any placed by him on the market a medical device and has to ensure that it meets the legal requirements . The proof of product safety is the conformity assessment procedure .

As illustrated in the part of the general meaning of the CE marking, the assessment of conformity generally does not take place with the participation of an authority or inspection ( " Notified Body " ), but rather in ownership by the manufacturer.


a) Role of the Notified Body in the conformity assessment of medical devices

An exception to this rule applies in the field of medical devices , as these generally have an increased hazard potential in comparison to other products, so that external supervision appropriate. With the exception of medical devices in Class I without measuring function and non-sterile medical devices of class I is required as part of the conformity assessment of medical devices from inclusion of an external expert auditing and certification body . This be " notified body" has been designated by a Member State to carry out the conformity assessment and have their registered office in a Member State , therefore, not necessarily in Germany .

If a Notified Body in the conformity assessment procedure has been involved , points out the four-digit identification number of the Notified Body which, if present at the CE marking in accordance with the CE logo .


b) procedures for conformity assessment of products of class I

Since medical devices in Class I only have a low hazard potential , the manufacturer or his authorized representative may make these products at their own responsibility and explain that the relevant provisions of the Directive are met .

He created the technical documentation and shall make the labeling of products . This form of conformity assessment is referred to as " EC Declaration of Conformity " and is determined in accordance with Annex VII to Directive 93/42/EEC.

For medical devices in Class I with measuring function or sterile Class I procedures according to Annex IV , V or VI of the Directive is additionally restricted to go through each of the specific requirements .


c) procedures for conformity assessment of products in Class IIa

As part of the conformity assessment of medical devices in Class IIa in connection to the above-mentioned method of " EC Declaration of Conformity " one of the following method also optionally be applied :

Restricted procedures ' EC verification " as limited product testing according to Annex IV of the Directive. To start with, the proof must be provided that the product meets the essential requirements of Annex I of the Directive. In addition, the manufacturer must take all measures necessary here to ensure the conformity of all products of a product line with the requirements laid down by the Directive requirements in the production process . A Notified Body checks the conformity of the products with the technical documentation referred to in Annex VII, Section 3 of the Directive.

Restricted procedure of " EC declaration of conformity ( production quality assurance) " under Annex V of the Directive. Here is also first necessary to demonstrate that the product meets the essential requirements of Annex I of the Directive. As part of the production and final inspection of the manufacturer shall apply an approved quality assurance procedures , which is audited and monitored by a Notified Body . The Quality Assurance process , the manufacturer shall ensure that its products comply with the technical documentation are manufactured in accordance with Annex VII of the Directive.

Restricted procedure of " EC declaration of conformity ( product quality assurance) " in accordance with Annex VI of the Directive. Here is also first necessary to demonstrate that the product meets the essential requirements of Annex I of the Directive. In addition, an approved quality assurance procedures for final inspection of the medical device is necessary in need of auditing and monitoring by the Notified Body . The Quality Assurance process ensures the manufacturer that its products in accordance with the technical documentation are prepared in accordance with Annex VII of the Directive.

Restricted procedure of " EC declaration of conformity (full quality assurance system) " in accordance with Annex II of the Directive. Here is first necessary to demonstrate that the product meets the essential requirements of Annex I of the Directive. In addition, an approved quality assurance system must be in place which is audited and monitored by the Notified Body and the design, manufacture and final inspection of the product includes .


d ) procedures for the evaluation of conformity of the class IIb products

For Class IIb medical devices , the manufacturer must perform according to his choice of the following conformity assessment procedures :

Restricted procedure of " EC Conformity Assessment (full quality assurance system) " in accordance with Annex II of the Directive. From the Manufacturer thereby an approved quality assurance system must be available that is audited and monitored by the Notified Body and the design, manufacture and final inspection of the product includes .

Method of " EC type examination " referred to in Annex III of the Directive. Under this procedure, the manufacturer of the notified body shall supply a representative specimen from the production including documentation as a model . The Notified Body certifies that the manufacturer then that this form complies with the relevant provisions of the Directive and review and evaluate the information provided in the documentation. Apply this method in each case by the method of 'EC verification " , the process of " EC declaration of conformity (production quality assurance ) "or the process of " EC declaration of conformity ( product quality assurance) "


e) procedures for conformity assessment of class III

Manufacturers of medical devices of the riskiest class III shall alternatively comply with one of the two following methods :

Method of " EC declaration of conformity (full quality assurance) " in accordance with Annex II of the Directive. In addition , the interpretation documentation are checked for product by a notified body before making the product. These provide the manufacturer then an "EC design-examination certificate " from .

Method of " EC type examination " in connection in connection with the method of the 'EC verification " in accordance with Annex IV of the Directive or the process of " EC declaration of conformity ( production quality assurance) " in Annex V of the Directive.


f ) Declaration of Conformity

Before the manufacturer must place his product after passing through the conformity assessment procedure in traffic , he shall or in exhibition of his authorized representative established in a written declaration of conformity for the product.

With this declaration, I declare that the product to be brought on the market complies with all relevant safety requirements.




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