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חדש
MDR Master ClassUpdates on latest developments in the EU
The last of the dates for getting your contract upgraded to MDR has passed. That means that
- you can place your MDD certified products until the
- end 2027 (high risk) or
- end 2028 (medium/low risk) on the EU...המשך קריאה
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
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
למי זה מתאים?
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 MDR
מי מעביר את הקורס?
