Professional Certificate in EU MDR Framework
-- ViewingNowThe Professional Certificate in EU MDR Framework is a comprehensive course that empowers learners with the essential skills needed to navigate the complex regulatory landscape of the European medical device industry. This course is crucial in the current industry context, where the EU Medical Device Regulation (MDR) has replaced the Medical Device Directive (MDD), demanding a profound understanding of the new regulatory framework.
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⢠EU MDR Fundamentals
⢠Overview of EU MDR Framework
⢠Key Changes in EU MDR vs MDD
⢠EU MDR Classification Rules
⢠Clinical Evaluation & Investigations
⢠Technical Documentation & Labeling Requirements
⢠Vigilance & Post-Market Surveillance
⢠EU MDR Compliance Strategy & Timeline
⢠Notified Body Selection & Collaboration
⢠EU MDR Implementation Challenges & Best Practices
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