Webinar
Medical Devices

MDR Conformity Assessment Routes in the AIMD Space

A SMEs tailored overview of the MDR Conformity Assessment Routes.

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Gaining a better understanding of MDR Conformity Assessment Routes

Presenting an overview of the MDR Conformity Assessment Routes, the application process and BSI approach, tailored to SMEs in the AIMD space.

Discuss classification of devices including accessories.
How to preparing a comprehensive technical documentation package.
Provide general lessons learnt about review timelines and associated service levels at BSI.
Challenges in the CE marking process.

MDR Conformity Assessment Routes in the AIMD space

An overview of the MDR Conformity Assessment Routes, the application process and the review approach of BSI, tailored to SMEs in the AIMD space.

Thomas Doerge, Global Head Active Implantable Medical Devices, BSI

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