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MDR Master ClassThe latest update information on implementation of the MDR (EU Regulation 2017/745)
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
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Issues to be covered
- Day 1: Update on latest news from Brussels (Commission MDR Rolling plan status, Update on NB designations, Status of MDCG guidance development, Discussion on content of some latest MDCG guidances)
- Day 2: QMS and TD requirements: Article 10+Annex IX vs EN ISO 13485; Technical dossier requirements; Discussion on findings made during audit and TD review.
- Day 3: Eudamed – Available modules – live demonstration of Eudamed through playground environment. If time allows – latest in UDI.
- Day 4: Clinical evaluation, PMS and PMCF
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
