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Process Failure Mode and Effects Analysis (PFMEA) is the most widely used tool for process risk analysis in Medical Devices. Although ISO 14971 does not demand a specific tool to be used for process risk management it very well states, that risks should be managed by systematically using experience, insight and judgment. In general, a

Medical device manufacturers face a lot of efforts caring about the information of the product design, test and production. Such information must be available in a human readable format at least 10 years after the last product was put on the market (15 years for implantable products). If a medical device manufacturer or even the

Notified Body GMED (France) is No.15 on the NANDO database to receive MDR designation. Read more

The European Council and the European Parliament postponed the Date of Application (DoA) for 1 year for Medical Device Regulation (MDR) 2017/745 due to COVID-19 crisis. At this time just 13 Notified Bodies are designated under the MDR legislation.

The draft standardisation request for MDR and IVDR was submitted to the Committee on Standards with the need to provide an adequate legal basis for the development of harmonised European standards and been issued to CEN and CENELEC, the European Standardisation Organisations. Annex I of this request lists the existing standards to be revised, and

Swiss Medtech recommends Swiss medical device manufacturers to fulfill requirements of a third country manufacturers at the 26 May 2020. This means especially to have an Authorised Representative in place. Read more

Swiss Medtech recommends to manufacturers to prepare on worst case scenario regarding situation with Mutual Recognition Agreement. Have you already considered to work with service provider EUMEDIQ as Authorised Representative? Read more