Masterclass Certificate in Medical Device Compliance Standards
-- ViewingNowThe Masterclass Certificate in Medical Device Compliance Standards is a comprehensive course that equips learners with the essential skills needed to navigate the complex world of medical device regulations. This program focuses on the importance of compliance standards, their impact on the medical device industry, and the crucial role they play in bringing safe and effective products to market.
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โข Regulatory landscape for medical devices
โข Understanding ISO 13485:2016 โ Quality management system for medical devices
โข European Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746
โข US Food and Drug Administration (FDA) medical device compliance
โข Design controls and risk management for medical devices
โข Clinical investigations and performance studies
โข Post-market surveillance and vigilance
โข Medical device labeling, instructions for use, and UDI systems
โข Global harmonization and convergence in medical device standards
โข Preparing for and managing regulatory inspections and audits
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