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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โข Regulatory Foundations for IVDs: Understanding the Legal Landscape
โข IVD Classification: Defining the Risk and Regulatory Requirements
โข Quality Management Systems: Implementing ISO 13485 for IVDs
โข Clinical Evidence: Designing and Conducting Clinical Studies for IVDs
โข Labeling and Instructions for Use: Ensuring Compliance with FDA and EU Regulations
โข Pre-market Notification (510(k)): Navigating the FDA Submission Process for IVDs
โข European Union (EU) Regulatory Affairs: Mastering the In Vitro Diagnostic Medical Device Regulation (IVDR) and Conformitรฉ Europรฉene (CE) Marking
โข Post-market Surveillance: Managing Adverse Event Reporting and Post-market Clinical Follow-up for IVDs
โข Global Harmonization: Exploring International Regulatory Standards for IVDs
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