Certificate in EU Medical Device Certification
-- ViewingNowThe Certificate in EU Medical Device Certification course is a comprehensive program designed to equip learners with the necessary skills to excel in the medical device industry. This course is crucial in the current industry landscape, where the demand for professionals with a deep understanding of EU medical device regulations is at an all-time high.
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Here are the essential units for a Certificate in EU Medical Device Certification:
โข EU Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)
โข Understanding the Conformity Assessment Process
โข Quality Management Systems for Medical Devices
โข Clinical Evaluation and Technical Documentation
โข EU Medical Device Vigilance and Post-Market Surveillance
โข Understanding Notified Bodies and their Role in EU MDR/IVDR
โข EU Medical Device Classification and Risk Management
โข EU Medical Device Labeling and UDI Requirements
โข Preparing for and Passing the EU MDR/IVDR Certification Audit
โข Changes and Challenges in EU Medical Device Certification under MDR/IVDR
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