Global Certificate in AM Regulatory Strategy
-- ViewingNowThe Global Certificate in AM Regulatory Strategy course is a comprehensive program designed to empower professionals with the necessary skills to navigate the complex world of additive manufacturing (AM) regulations. This course is crucial in a time when the AM industry is rapidly growing, and there is an increasing demand for experts who can help companies comply with regulatory requirements.
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⢠Global AM Regulatory Framework: Overview of global regulatory bodies and their jurisdictions, including FDA, EMA, TGA, and others.
⢠Medical Device Classification: Explanation of medical device classes, their definitions, and regulations in various regions.
⢠Regulatory Pathways: Comparison of premarket approval, 510(k), and other regulatory pathways in relevant jurisdictions.
⢠Quality Management System: Overview of ISO 13485 and its role in medical device regulation.
⢠Clinical Evaluation and Trials: Requirements and best practices for clinical evaluation and trials in global markets.
⢠Labeling and Instructions for Use: Guidelines for labeling, language, and instructions for use in different regions.
⢠Post-Market Surveillance: Overview of post-market surveillance, vigilance, and reporting requirements.
⢠Regulatory Compliance and Audits: Strategies for maintaining compliance, internal audits, and responding to regulatory inspections.
⢠Regulatory Affairs Organization: Building and managing a regulatory affairs department and its interactions with other functions.
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