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:
⢠EU Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)
⢠Understanding the Conformity Assessment Process
⢠Quality Management Systems for Medical Devices
⢠Clinical Evaluation and Technical Documentation
⢠EU Medical Device Vigilance and Post-Market Surveillance
⢠Understanding Notified Bodies and their Role in EU MDR/IVDR
⢠EU Medical Device Classification and Risk Management
⢠EU Medical Device Labeling and UDI Requirements
⢠Preparing for and Passing the EU MDR/IVDR Certification Audit
⢠Changes and Challenges in EU Medical Device Certification under MDR/IVDR
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