Regulatory Strategy
17 JUN 2021

New Frontiers of Biomedical Devices Testing

Part 2

Online 13:30 BST

Second meeting with focus on safeguarding human health and animal lives and MDR application for Manufacturers of active devices.

The journey through the world of Medical Devices continues. From the implementation MDR to the new strategies proposed by the ISO 10993 series, many are the innovations. Among those a very important part is constituted by the Reduce/Refine/Replace (RRR) approach concerning animal lives defense. Beyond that devices’ categories such active devices are going to impacted by specific BCT data coming from MDR requirements.

TÜV SÜD Group, by means of pH Lab, active in Biocompatibility Chemical Testing (BCT), is in the optimal position for giving a helpful contribution in the process leading to regulatory conformity.

Highly expert personnel both from the Notified Body TÜV SÜD Product Service in Munich and the pH Laboratory in Barberino Tavarnelle (Chianti, Tuscany) herewith provide their experiences with the hot topics of the moment.


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