Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training
1 Day - 0.8 CTUs - $1395
This course will provide authoritative overview of topics for medical device manufacturers transitioning from their existing Medical Device Directive (MDD) to the new Medical Device Regulations (MDR) to place their devices into the E.U. market.
Who This Course Is For
Medical Device manufacturers, designers and developers, regulatory and clinical affairs personnel, quality assurance managers and those involved in marketing medical devices to the EU market.
- Gain an overview of the structure of the new MDR
- Be familiar with key changes in the requirements for CE Marking
- Be familiar with changes in device definitions and MDR terminology
- Recognize significant aspects affecting the device manufacturer
- Understand the range of technical documentation required
- Understand the role of economic operators
- Know the key changes impacting conformity assessment
- Be familiar with the transition timeframes, recently modified
- Explore some priority areas of impact requiring early planning