BEO MedConsulting Berlin GmbH of Berlin at REHACARE 2017 in Düsseldorf -- REHACARE Trade Fair

BEO MedConsulting Berlin GmbH

Helmholtzstr. 2, Aufg. A, 10587 Berlin
Germany

Telephone +49 30 31804530
Fax +49 30 31804540
info@beoberlin.de

Hall map

REHACARE 2017 hall map (Hall 6): stand F28

Fairground map

REHACARE 2017 fairground map: Hall 6

Contact

Eszter Boros

Phone
+49(0)30 / 318 045 30

Email
e.boros@beoberlin.de

Olaf Meyer

Division Manager Marketing and Sales

Phone
+49(0)30 / 318 045 30

Email
o.meyer@beoberlin.de

Our range of products

Product categories

  • 02  Apprenticeship, workplace and occupation
  • 02.26  Further training and qualification

Further training and qualification

  • 12  Associations, organisations, nursing residents, services
  • 12.05  Advices and information on assistive devices
  • 12  Associations, organisations, nursing residents, services
  • 12.12  Other organisations, institutions

Other organisations, institutions

Our products

Product category: Other organisations, institutions

Expert Appraisal

Proof of medical benefit in the form of an expert opinion (case studies) is mandatory for certain medical devices to become registered in the German Health Aid List (Hilfsmittelverzeichnis – HMV). Qualitative appropriate medical assessment and specific parameters are necessary to prove the product’s medical benefit. This applies, for example, for orthotics / splints, therapeutic exercise equipment, bandages, mattresses among other devices.

These expert opinions are not equivalent to Clinical Evaluations for CE documentation. Expert appraisal is a special request for German reimbursement by the statutory health insurance funds. Naturally, the expert appraisal can be used as a literature source for Clinical Evaluations.

Due to many years of experience and contacts with health-care institutions and professionals, BEO BERLIN® is able to create respective expert opinions within reasonable time.

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Product category: Further training and qualification

Seminars

No matter the continent or country, medical-device industry is always a challenge. Participants need to be familiar with the general legal framework as well as specific regulations. Above all, they need to be able to fulfil their respective requirements. Our consultants have gathered significant knowledge and experience in the regulatory aspects of medical devices. Apart from individual consultancy, we also offer seminars and workshops to present general frameworks and procedures.


Below you can find our current workshops. Nevertheless, feel free to approach us with your specific seminar requests on any of our services.

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Product category: Advices and information on assistive devices

Clinical Evaluation

Clinical evaluation of medical devices plays a key role in a thorough CE-documentation. It becomes important already in product registration and market entry as well as in later stages of medical-device market monitoring.
According to Medical Device Directive 93/42/EEC and, respectively, in the German Medical Devices Act (Medizinproduktgesetz – MPG), the clinical evaluation is part of the technical documentation and of the conformity assessment. Therefore, it must be submitted at the registration for every medical device, independent of risk category.

A clinical evaluation needs to be conducted on the basis of objective and documented medical criteria and under the direct supervision of a medical expert. Normally, the European MEDDEV 2.7.1 on Clinical Evaluation is used as reference point. It provides method and procedure guidelines for manufacturers and notified bodies. It also defines the criteria applicable for clinical evaluation conduct and assessment.

According to the German Medical Devices Act §19 paragraph 1 and 93/42/EEC directive Attachment X paragraph 1, manufacturers are required to prove suitability for intended usage as well as to perform medical risk assessment for every medical device. This has to take places in the framework of clinical data evaluation. These data have to derive from already existing clinical studies, medical literature, own studies and/or own clinical investigations.

In the clinical evaluation, the product and process risks have to be represented in detail with a respective critical expert opinion. This requirement applies to the usage, risks as well as the defined product features.

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Product category: Advices and information on assistive devices

Registration in the German Reimbursement System ( Hilfsmittelverzeichnis)

To encourage competition among the statutory health insurance funds, a new law entered into force on 1 April 2007. Further changes for medical aid provision were defined in the laws for the development of organizational structures in statutory health insurance, 1 January 2009. Later, further organizational and contract-related conditions were defined. Among others, these laws introduced the following requirements.

  • The introduction of a so-called centralized prequalification process of health-care providers
  • Medical-device tender modification: from “should” to “able to”-provisions
  • Recommendation on functionality of medical device tenders
  • Introduction of membership right of health care providers to existing medical device contracts
Health aids are materials or medical services which can be covered by the German statutory health insurance. Medical-device manufacturers and health-care providers have to carefully follow the service and product quality requirements as they are stated in the German Health Aid List (Hilfsmittelverzeichnis – HMV). The legal basis for HMV remains to be the German Social Legal Code (Sozialgesetzbuch - SGB) §33 and § 34.

In order to register a medical device in the HMV and thereby fulfil its requirements, manufacturers have to overcome various obstacles. The Association of Statutory Insurance Funds (Gesetzliche Krankenversicherung Spitzenverband) expects a complete and spotless submission of proofs and certificates which satisfies the requirements and quality of the distributors. Mistakes in the registration documents can lead to delays in market entry as well as tender processes. BEO BERLIN® can help you avoid such mistakes.

Our services
  • Initial product conformity test
  • Document supervision for completeness and appropriateness
  • Product design conformity advice
  • User manual, risk analysis, clinical studies etc. preparation
  • Testing and expert appraisal coordination, where applicable
  • Contact person and representative
  • Registration package submission
  • Individually tailored process

Since 2003, we have assisted and successfully registered 2500 medical devices. After successful registration, the product receives a 10-digit HMV-number, which can make sales activities and communication with health-care providers easier.

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Product category: Advices and information on assistive devices

CE documentation

Medical devices brought to the market must display the CE mark. It proves that the product meets requirements of Medical Device Directive 93/42/EEC. The CE mark is based on a technical documentation and on an extensively documented assessment procedure.

Manufacturers have to identify which directives are relevant and whether all criteria are fulfilled. If necessary, a notified body must be consulted for conformity assessment. Then the technical files must be prepared, often accompanied with product tests. This technical documentation includes product description, risk analysis, a list of the relevant directives and harmonized norms, product-accompanying documents, checklist for essential requirements, design and test certification, design and supplier documentation, clinical evaluation, among others. After certification, manufacturers have to affix the mark to their product.

You can choose us to be your partner when it comes to dealing with notified bodies or product tests and evaluations. You can read our specific services by clicking on the link right side. We can assist you to become compliant with the requirements that you, your medical device and your documentation have to meet.

Our services:
  • Risk Analysis
  • Clinical Evaluation
  • Usability
  • Software Validation
  • User Manual
  • Testing
  • Seminars

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About us

Company data

Number of employees

1-19

Foundation

2000

Area of business

Associations, organisations, nursing residents, services