Advanced Certificate in Biomedical Tech Regulatory Strategy
-- ViewingNowThe Advanced Certificate in Biomedical Tech Regulatory Strategy equips learners with the necessary skills to navigate the complex regulatory landscape of the biomedical technology industry. This course is vital for professionals aiming to advance their careers in this field, as it provides in-depth knowledge of regulatory strategies, compliance, and quality assurance.
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Here are the essential units for an Advanced Certificate in Biomedical Tech Regulatory Strategy:
โข Regulatory Affairs Overview
โข Understanding FDA Regulations and Guidelines
โข Biocompatibility and Safety Testing for Biomedical Devices
โข Quality System Regulation (QSR) and ISO 13485 Compliance
โข Design Controls and Risk Management for Biomedical Devices
โข Clinical Trials and Post-Market Surveillance
โข Preparing and Submitting 510(k) Premarket Notifications
โข European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR)
โข Global Regulatory Strategy for Biomedical Devices
โข Emerging Trends in Biomedical Tech Regulatory Strategy
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