The new legislation on medical devices in the EU, MDR and IVDR has greatly influenced the need for the renewal of medical device standards. This need has led to the development of completely new standards, and previous releases have been revised, to reflect the new law (MDR and IVDR) and developments on the international market. Things that are highlighted and have been included is information from manufacturers, new symbols, follow-up of products already released on the market (Post Market Surveillance) and updated risk management process.
QAdvis consultants Anneli Wiedenkeller and Cristina Albu Barkman has been involved in the renewal of medical device standards and are participating on webinars organized by SIS. All three webinars are held in Swedish.
Take the opportunity to update yourself in the field of medical device standards, listen to QAdvis Senior Quality and Regulatory Consultants, Anneli Wiedenkeller and Cristina Albu Barkman!