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MDR Master ClassUpdates on latest developments in the EU
Help us make this masterclass more effective – submit your cases and questions in advance! The success of the masterclass depends on it! After signing-up to the masterclass, send your cases and questions to gad@bakc.co.il
Due to the Covid-19 pandemic, the EU Commission has decreed that the date of application of the MDR was postponed with one...Continue reading
Have a question? We got all the answers
Issues to be covered
During the masterclass, the participants can upfront ask specific questions. They will be integrated in the subjects as identified below.
- Day 1: Update on latest news from Brussels (Update on NB designations, latest MDCG guidances, EU Dashboard on certification status, impact amendment MDR/IVDR – Eudamed – notification requirements, any other latest developments) – Specific questions from participants
- Day 2: QMS and TD requirements: Article 10+Annex IX vs EN ISO 13485; Technical dossier requirements; Labeling and language requirements; Discussion on findings made during audit and TD review; Role PRRC. Specific questions from participants
- Day 3: Clinical evaluation – CEP, CDP, CER – linkage to RM, SSCP
- Day 4: PMS – PSUR and PMCF+PMCFER – linkage to Clinical and RM
Who should attend
Specifically PRRCS will benefit from the information provided
This Master Class is not suitable for beginners, as it will not discuss the fundamentals of the MD
About The Lecturer
