MDR Conformity Assessment Routes in the AIMD space

MDR Conformity Assessment Routes in the AIMD space

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MDR Conformity Assessment Routes in the AIMD space
MDR Conformity Assessment Routes in the AIMD space
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A SMEs tailored overview of the MDR Conformity Assessment Routes in the AIMD space

Sprache: Englisch

 

What is the webinar about?

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

Who should attend?

All SMEs who intend to apply for CE marking under the Medical Device Regulation. Manufacturers interested in gaining a better understanding of MDR Conformity Assessment Routes are also welcomed to join.

What will participants gain?

We will talk about the classification of devices including accessories, points to consider in preparing a comprehensive technical documentation package and provide general lessons learnt about review timelines and associated service levels BSI can offer.

Watch on demand

Our speakers

Thomas Doerge

Thomas Doerge, Global Head of Active Implantable Medical Devices (AIMD), Regulatory Services, BSI

Thomas has over 20 years’ experience in Research and Development of AIMD products specifically in the field of neuromodulation. He has an in-depth knowledge of Biomedical Engineering, Biomedical Microsystems and Medical Engineering. He also has great experience in Neuroprosthetics, which includes micro-structuring, manufacturing, wireless energy and signal transmission as well as the characterisation of active implantable systems.

Thomas leads a global team of 22 Product Technical Specialists and dedicated clinical experts, who are not just experienced in the regulatory process, but who are product experts who understand the specifics of active implantable products.