Part 1: Safety Assessment of Medical Devices

Explore approaches to safety evaluation

The new EU Medical Device Regulation (MDR) increases the focus on assessing and documenting the safety of medical devices. In a series of three webinars, this first webinar gives you an overview of the requirements in the MDR and updates to the ISO 10993-series. We address how to approach the safety evaluation and point out useful standards and guidelines to ensure compliance (~50 min). Please note that this webinar was recorded in late 2019. Since then the European Commission has postponed implementation of the MDR until 26 May 2021. This does not affect the guidance and relevance of the webinar.

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