Global Certificate in Regulatory Affairs for IVD Compliance
-- ViewingNowThe Global Certificate in Regulatory Affairs for IVD Compliance is a comprehensive course that equips learners with critical skills in the regulatory affairs sector, particularly for in vitro diagnostic (IVD) devices. This certification is crucial in the rapidly evolving medical device industry, where regulatory compliance is paramount.
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⢠Global Regulatory Overview for IVDs: Understanding the global regulatory landscape for In Vitro Diagnostic (IVD) devices, including key agencies and regulations
⢠Regulatory Strategy for IVDs: Developing a regulatory strategy to ensure compliance with IVD regulations, including gap analysis and risk management
⢠Quality Management System (QMS) for IVDs: Implementing and maintaining a QMS for IVDs, including ISO 13485 and FDA QSR requirements
⢠IVD Design and Development: Designing and developing IVDs in compliance with regulations, including design controls and documentation requirements
⢠IVD Manufacturing and Process Validation: Manufacturing IVDs in compliance with regulations, including process validation and cleaning validation
⢠IVD Labeling and Packaging: Ensuring compliance of IVD labeling and packaging with regulations, including UDI and IFU requirements
⢠IVD Clinical Evaluation and Performance: Conducting clinical evaluations and ensuring the performance of IVDs, including Leach and Walker review
⢠IVD Post-Market Surveillance: Implementing and maintaining post-market surveillance for IVDs, including adverse event reporting and vigilance
⢠Regulatory Submissions for IVDs: Preparing and submitting regulatory applications for IVDs, including 510(k) and CE Marking submissions
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