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BEO MedConsulting Berlin GmbH

Helmholtzstr. 2, Aufg. A, 10587 Berlin
Germany
Telephone +49 30 31804530
Fax +49 30 31804540
sales@beoberlin.de

Hall map

REHACARE 2019 hall map (Hall 6): stand E58

Fairground map

REHACARE 2019 fairground map: Hall 6

Contact

Team BEO Berlin

Phone
03021804530

Email
sales@beoberlin.de

Our range of products

Product categories

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

Advices and information on assistive devices

Our products

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.

The European legal environment for medical devices is changing. The goal is to create a more transparent and safer system for the user within the EU. A very important step on this road was the release of the Regulation 2017/745/EU on medical devices in May 2017, which will replace the Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.

The MDR was released in May 2017 but only becomes mandatory in 2020. Manufacturers have time until the end of the transition period. Nevertheless, it is highly recommended to start preparing, now, for the new requirements, since the new requirements according to Annex II and III of the MDR prescribe stricter and more elaborate documentation and proof obligations, for instance in the clinical evaluation.

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.

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Product category: Advices and information on assistive devices

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: Advices and information on assistive devices

Quality Management System

Quality Management System (QMS) is one of the greatest challenges in the medical device industry today. Certain manufacturers are legally required to work according to a certified QMS (ISO 9001 / ISO 13485). For others, it is simply a measure to indicate reliable, high-quality service. The implementation of QMS is definitely an advantage: customer satisfaction and a certificate confirm well-defined and well-organized processes.

For the QM certificate, the implementation of a custom-made QM-system is required, which needs manufacturer-specific solutions and not mass-produced instructions. Our team, experienced in the medical-device industry and with understanding of medical-device producers’ needs, is ready to assist you with the entire QMS setup and certification.

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About us

Company details

BEO BERLIN® has been in the field of medical devices since 2000. BEO MedConsulting Berlin GmbH has relocated its headquarters to the German capital in 2003. Berlin is an innovative and inspiring location for the medical device industry. The influx of major organizations and associations, such as the Association of the German Statutory Insurances (Gesetzliche Krankenversicherung Spitzenverband – GKV Spitzenverband), contributes to the city’s increasing importance in the medical world.

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Company data

Number of employees

1-19

Foundation

2000

Focus of supply
  • Daily living aids
  • Wheelchairs, vehicles
  • Mobility aids, walking aids
  • Others