Certificate in Global AM Regulatory Framework Navigation
-- ViewingNowThe Certificate in Global AM Regulatory Framework Navigation is a comprehensive course designed to empower learners with the necessary skills to navigate the complex regulatory landscape of the Additive Manufacturing (AM) industry. This course is crucial in a time when AM is rapidly transforming the manufacturing sector, leading to an increased demand for professionals who understand the global regulatory framework.
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โข Introduction to Global AM Regulatory Framework
โข Understanding Regulatory Bodies (FDA, EMA, etc.)
โข Global Regulatory Requirements and Compliance
โข Navigating Regulatory Pathways for AM Devices
โข Clinical Evaluation and Investigational Plans
โข AM Device Classification and Risk Management
โข Quality Management Systems in AM Regulation
โข Labeling, Packaging, and Sterility Requirements
โข Post-Market Surveillance and Vigilance in Global AM Regulation
โข Strategies for Successful Regulatory Navigation in AM
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