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Course Details

Active Implantable Medical Devices under the EU MDR

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Course Fee

No charge

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Course Details

Thomas Doerge, Global Head Active Implantable Medical Devices at BSI, discusses technical documentation requirements under the EU Medical Device Regulation. He focuses on the obstacles they see as a Notified Body, software design, and clinical evidence to support active implantable medical devices when submitting documents for an MDR application.

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