Masterclass Certificate in IVD Regulatory Affairs Documentation Essentials
-- ViewingNowThe Masterclass Certificate in IVD Regulatory Affairs Documentation Essentials is a comprehensive course that equips learners with critical skills in the regulatory documentation of In Vitro Diagnostic (IVD) devices. This course is crucial in the context of the rapidly evolving IVD industry, where compliance with complex regulatory requirements is paramount.
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⢠IVD Regulatory Affairs Overview
⢠Understanding IVD Directives and Regulations
⢠Essentials of IVD Documentation: Designing and Developing
⢠IVD Labeling and Instructions for Use
⢠Clinical Evidence and Performance Evaluation Reports
⢠Quality Management System for IVDs
⢠Post-Market Surveillance and Vigilance
⢠IVD Regulatory Submissions and Approvals
⢠Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF)
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