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Course Details

An overview of the MDR Conformity Assessment Routes in the AIMD space

Student taking online training

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand

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Course Details

Agenda

1. Understanding AIMDs
2. Notified Body Landscape
3. MDR Conformity Assessment Route
4. Classification of AIMDs
5. 5 steps to CE marking or UKCA with BSI
6. CE marking process at BSI
7. Challenges in the CE marking process
8. Why BSI

Presenter Information

Jazzmyne Buckels - Technical Team Manager, Active Implantable Medical Devices BSI

Thomas Doerge - Global Head, Active Implantable Medical Devices BSI

Simon Lidgate - Technical Team Manager, Active Implantable Medical Devices BSI

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