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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โข EU MDR Fundamentals
โข Overview of EU MDR Framework
โข Key Changes in EU MDR vs MDD
โข EU MDR Classification Rules
โข Clinical Evaluation & Investigations
โข Technical Documentation & Labeling Requirements
โข Vigilance & Post-Market Surveillance
โข EU MDR Compliance Strategy & Timeline
โข Notified Body Selection & Collaboration
โข EU MDR Implementation Challenges & Best Practices
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