Advanced Certificate in Medical Device Regulatory Transformation
-- ViewingNowThe Advanced Certificate in Medical Device Regulatory Transformation is a comprehensive course designed to empower professionals with the latest regulatory knowledge and skills required in the medical device industry. This certificate program addresses the increasing demand for experts who can navigate complex regulatory landscapes and ensure compliance with rapidly evolving regulations.
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โข Advanced Medical Device Regulations Overview
โข Global Harmonization Task Force (GHTF) and International Medical Device Regulatory Frameworks
โข Quality System Regulation (QSR) and ISO 13485:2016 โ Comparison and Contrast
โข European Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746
โข US FDA Pre-Market Approval (PMA), 510(k), and De Novo Pathway โ Strategies and Best Practices
โข Post-Market Surveillance, Vigilance, and Reporting in Medical Device Regulation
โข Medical Device Single Audit Program (MDSAP) โ Benefits and Implementation
โข Combination Products โ Regulation, Classification, and Compliance
โข Clinical Evaluation, Clinical Data, and Clinical Investigation for Medical Devices
โข Risk Management and Usability Engineering in Medical Device Design and Development
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