BEO MedConsulting Berlin GmbH

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

This company is main exhibitor of

Hall map

REHACARE 2018 hall map (Hall 3): stand C30

Fairground map

REHACARE 2018 fairground map: Hall 3

Our range of products

Product categories

  • 02  Apprenticeship, workplace and occupation
  • 02.26  Further training and qualification
  • 12  Associations, organisations, nursing residents, services
  • 12.05  Advices and information on assistive devices

Advices and information on assistive devices

  • 12  Associations, organisations, nursing residents, services
  • 12.12  Other organisations, institutions

Our products

Product category: Further training and qualification, Advices and information on assistive devices, Other organisations, institutions

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: Further training and qualification, Advices and information on assistive devices, Other organisations, institutions

EU Authorized Representative

Entering the European market from outside the European Union is a complex and lengthy process. Medical-device manufacturers have to familiarize themselves with EU-wide and country-specific knowledge and register their products in the respective data bases. It is mandatory for manufacturers to acquire the CE mark and to designate an authorized representative, as prescribed in European Directive 93/42/EEC. An authorized representative becomes the medium between the manufacturer and any authority within the EU. They also appear as point of primary contact on all documentation and product packaging.

We have acquired relevant information and built a thriving network in the field. Accordingly, we can advise you and serve as your EU Representative of choice.

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Product category: Further training and qualification, Advices and information on assistive devices, Other organisations, institutions

HMV Representative

For reimbursement in Germany, home-care products need to be registered in the so-called Hilfsmittelverzeichnis (German Health Aid List).
What are the exact requirements? What can we do for you?

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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.

BEO BERLIN® Biography:
2000: founding
2003: headquarters in Berlin
2003: HMV-registration in the service portfolio
2008: BEO GmbH – limited liability company
2009: BEO BERLIN® registered brand
2009: partnership with Bioteco s.r.l. (formerly Biascon s.r.l.)
2012: affiliate agreement with UK HealthGateway
2013: recognized “Präqualifizierungsstelle” (Admission Authority for German healthcare-providers)
2014: partnership with GloriMed Consulting SAS
2015: EUMMAN (EUropean Medical Market Access Network) Partnership
2015: Cooperation "Medical Experts Alliance"

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