MDR Master Class - ביופורום

MDR Master ClassUpdates on latest developments in the EU

בהדרכת: Mr. Robert Van Boxtel, Mr. Vincent van der Meer

תחומים: אביזרים ומכשור רפואי (אמ"ר), מומחים מחו"ל, רגולציה - תקינה

מק"ט: 258001

גרסה להדפסה

נווט אותי לשם

עמוד הבית הקורסים MDR Master Class

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

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 market
you missed the deadline, and have to get a contract with a NB without the advantages of keeping MDD products on the market

What if you are a new company? Should you go USA first? Or is the fog clearing up in the EU?

Join us for a masterclass on the latest developments in EU with regard to the MDR:

Impact latest amendments
Discuss the status of MDCG guidances
Will Eudamed ever be implemented
PMS – results of an investigation of the Dutch Inspectorate (competent authority under the MDR)

Bring your own questions and submit them upfront to gad@bakc.co.il

תאריכים: יפורסם בקרוב.
הקורס יפתח על פי רמת ההתעניינות בנושא.

מתעניינים? לחצו כאן

מיקום הקורס: מקוון באמצעות ZOOM

משך הפעילות: 4 מפגשים 1.5 שעות כל מפגש

שעות: 17:30 - 16:00

נקודות זכות: 2

שפת הקורס: English

עלות הקורס המלאה: 2,550 ₪ + מע"מ

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