Executive Development Programme in Medical Device Regulatory Affairs for the Future
-- ViewingNowThe Executive Development Programme in Medical Device Regulatory Affairs for the Future is a certificate course designed to empower professionals with the necessary skills to navigate the complex regulatory landscape of the medical device industry. This programme emphasizes the importance of regulatory compliance and its critical role in bringing innovative medical devices to market, ensuring patient safety, and driving business success.
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โข Fundamentals of Medical Device Regulatory Affairs
โข Global Regulatory Landscape for Medical Devices
โข Quality Management Systems and ISO 13485
โข European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
โข US Medical Device Regulations (FDA) and Pre-market Approval (PMA) process
โข Regulatory Strategies for Medical Device Innovation
โข Clinical Evaluation and Post-Market Surveillance
โข Medical Device Cybersecurity and Data Privacy
โข Global Harmonization and Mutual Recognition Agreements
โข Future Trends in Medical Device Regulatory Affairs
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