Masterclass Certificate in Regulatory Affairs for IVDs
-- ViewingNowThe Masterclass Certificate in Regulatory Affairs for IVDs is a comprehensive course that provides learners with critical skills in the regulatory affairs sector, specifically for In Vitro Diagnostic (IVD) devices. This course is essential for professionals seeking to navigate the complex regulatory landscape and ensure compliance with IVD regulations.
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โข Introduction to Regulatory Affairs for IVDs: Understanding the regulatory landscape, key players, and regulations for In Vitro Diagnostic devices (IVDs)
โข Classification of IVDs: Learning the risk-based classification system for IVDs and its impact on regulatory requirements
โข Quality Management System (QMS): Implementing a QMS in compliance with ISO 13485 and FDA Quality System Regulation
โข Clinical Evidence and Performance Evaluation: Generating and reporting clinical data to demonstrate the safety and performance of IVDs
โข Labeling and Instructions for Use (IFU): Designing and reviewing labeling and instructions for proper use of IVDs
โข Pre-market Notification (510(k)) and Approval (PMA): Navigating the FDA's pre-market review process for IVDs
โข European Union (EU) Regulations for IVDs: Compliance with EU IVD Regulation (EU) 2017/746 and In Vitro Diagnostic Medical Device Regulation (IVDR)
โข Post-market Surveillance and Vigilance: Implementing strategies for monitoring, reporting, and analyzing post-market data for IVDs
โข Global Harmonization and International Regulations: Staying updated on global regulatory trends and international standards for IVDs
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