The update of product group 08 insoles and product group 32 therapeutic activation devices was recently published.
BEO BERLIN supports manufacturers of medical devices with regulatory requirements.
BEO BERLIN supports manufacturers of medical devices with regulatory requirements.
We can efficiently support you with the conformity assessment procedure according to MDD/MDR, the application for an HMV code and implementation of a QM system.
We can handle your regulatory requirements for you, including by preparing individual documents, evalluations, complete documentation or applications.
We can assist you with required testing and case reports to ensure your verification procedure is fully recognised, from product testing to successful test report.
The update of product group 08 insoles and product group 32 therapeutic activation devices was recently published.
Update: From July 2021 on a separate individual code must be requested for each aid in France.
Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.
EUDAMED is the database developed by the European Commission for the registration of economic actors and their medical devices.
DIN EN ISO 10651-5 (Project)
DIN EN ISO 11073-10101
DIN EN ISO 28399 (Draft)
DIN 33402-2
ISO 9241-971
DIN EN 10942 rev (Project)
BEO BERLIN advises manufacturers of medical devices on testing and approval procedures for market access.
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