Professional Certificate: EU MDR Compliance Mastery
-- viewing nowThe Professional Certificate in EU MDR Compliance Mastery is a critical course for professionals in the medical device industry. The EU Medical Device Regulation (MDR) introduces significant changes that impact the marketing and safety of medical devices in Europe.
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Course Details
• EU MDR
• Overview of EU MDR
• MDR Timeline and Transition
• Classification of Medical Devices under MDR
• MDR Requirements for Technical Documentation
• Clinical Evaluation and Post-Market Clinical Follow-up
• Vigilance and Post-Market Surveillance under MDR
• EU MDR Quality Management System
• UDI and Traceability under MDR
• Notified Bodies and Conformity Assessment under MDR
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