Masterclass Certificate in Medical Device Quality Standards Overview
-- ViewingNowThe Masterclass Certificate in Medical Device Quality Standards Overview is a comprehensive course designed to provide learners with a solid understanding of the quality standards and regulations in the medical device industry. This course emphasizes the importance of quality management systems, risk management, and regulatory affairs in ensuring the safety and efficacy of medical devices.
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โข Introduction to Medical Device Quality Standards
โข Understanding ISO 13485: Medical Devices โ Quality Management Systems
โข Key Principles of FDA Quality System (QS) Regulation and Medical Device Good Manufacturing Practices (GMP)
โข Risk Management in Medical Device Design and Production: ISO 14971
โข Unique Device Identification (UDI) System and Global Unique Device Identification Database (GUDID)
โข Medical Device Reporting and Adverse Event Handling
โข European Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR)
โข Implementing Quality Management System for Medical Device Startups
โข Internal and Supplier Audits for Medical Device Quality Assurance
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