Certificate in Regulatory Affairs for IVDs
-- ViewingNowThe Certificate in Regulatory Affairs for IVDs is a comprehensive course that equips learners with critical skills needed in the rapidly evolving In Vitro Diagnostic (IVD) industry. This program emphasizes the importance of regulatory compliance, ensuring the safety and efficacy of IVD devices.
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⢠Regulatory Foundations for IVDs: Understanding the Legal Landscape
⢠IVD Classification: Defining the Risk and Regulatory Requirements
⢠Quality Management Systems: Implementing ISO 13485 for IVDs
⢠Clinical Evidence: Designing and Conducting Clinical Studies for IVDs
⢠Labeling and Instructions for Use: Ensuring Compliance with FDA and EU Regulations
⢠Pre-market Notification (510(k)): Navigating the FDA Submission Process for IVDs
⢠European Union (EU) Regulatory Affairs: Mastering the In Vitro Diagnostic Medical Device Regulation (IVDR) and ConformitÊ EuropÊene (CE) Marking
⢠Post-market Surveillance: Managing Adverse Event Reporting and Post-market Clinical Follow-up for IVDs
⢠Global Harmonization: Exploring International Regulatory Standards for IVDs
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