Executive Development Programme in Device Regulatory Guidelines
-- ViewingNowThe Executive Development Programme in Device Regulatory Guidelines is a certificate course designed to provide learners with a comprehensive understanding of the regulations and guidelines governing medical devices. This program is crucial in an industry where staying compliant with regulations is paramount for business success and avoiding costly penalties.
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โข Introduction to Device Regulatory Guidelines
โข Understanding Regulatory Affairs in Medical Devices
โข Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF)
โข Key Regulatory Bodies: FDA (US), MHRA (UK), TGA (Australia), and MHLW (Japan)
โข Regulatory Classification of Medical Devices
โข Quality System Regulation (QSR) and ISO 13485:2016
โข Medical Device Labeling, Advertising, and Promotion Compliance
โข Clinical Trials and Post-Market Surveillance
โข Risk Management and Usability Engineering Controls
โข Strategic Approach to Medical Device Regulatory Affairs
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