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A SMEs tailored overview of the 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.
Global Head Active Implantable Medical Devices, BSI
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