הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
חדש
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...המשך קריאה
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
- Day 1 – update on news from Brussels and from NB’s. Includes latest implementing / delegated acts, MDCG guidances, Team NB guidance
- Day 2 – Eudamed – explanation of functionalities and demonstration in the playground environment
- Day 3 – Clinical evaluation – what questions are there in your team to get the CEP/CER established?
- Day 4 – PMS incl PMCF – what questions are there in your team to establish PMS and process resulting product data to D&D, RM and Clinical evaluation
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?
