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From MDD to EU MDR
Have a question? We got all the answers
Issues to be covered
Day 1:
- Introduction, including timelines
- Scope of the MDR (Article 1), new/revised important definitions (Article 2) and Eudamed
- Economic Operators – their roles, rights and responsibilities
- Impact for Health Institutes in the EU + Custom made devices
Day 2:
- Classification and Conformity Assessment routes
- QMS requirements – including comparison to ISO 13485:2016
- Annex I: General Safety and Performance Requirements
- Annex II: Technical Documentation requirements
- Post Market Surveillance, including vigilance, FSCA.
Who should attend
This course will be extremely useful for the persons working in regulatory and quality assurance departments, and equally important for project managers or CTO’s involved in development of new medical devices. Last but not least, as CEO of a medical device company, you will obtain a clear insight in the new EU requirements and the impact it will have on your business case or company.
Benefits to the Participants
At the end of the seminar, you will be able to draft your company’s action plan, enabling working towards EU MDR compliance throughout the lifecycle of a medical device.
About The Lecturer
