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:
⢠Regulatory Affairs Overview
⢠Understanding FDA Regulations and Guidelines
⢠Biocompatibility and Safety Testing for Biomedical Devices
⢠Quality System Regulation (QSR) and ISO 13485 Compliance
⢠Design Controls and Risk Management for Biomedical Devices
⢠Clinical Trials and Post-Market Surveillance
⢠Preparing and Submitting 510(k) Premarket Notifications
⢠European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR)
⢠Global Regulatory Strategy for Biomedical Devices
⢠Emerging Trends in Biomedical Tech Regulatory Strategy
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