Global Certificate in Biomedical Regulatory Affairs for Medical Devices
-- ViewingNowThe Global Certificate in Biomedical Regulatory Affairs for Medical Devices is a comprehensive course that equips learners with the essential skills needed to succeed in the medical device industry. This program emphasizes the importance of regulatory affairs in bringing innovative medical devices to market while ensuring compliance with global regulatory requirements.
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โข Global Regulatory Landscape: Overview of global regulatory bodies (FDA, EU MDR, etc.) and their requirements for medical devices
โข Medical Device Classification: Understanding classification rules and their impact on regulatory strategy
โข Quality Management Systems: Implementing and maintaining QMS for medical devices in compliance with ISO 13485
โข Clinical Evaluation and Investigations: Designing and conducting clinical trials, evaluating clinical data for regulatory submissions
โข Regulatory Submissions: Preparing and submitting technical files, design dossiers, and 510(k) applications
โข Labeling and Packaging: Ensuring compliance with global labeling and packaging regulations
โข Post-Market Surveillance: Managing post-market surveillance, vigilance, and reporting requirements
โข Regulatory Affairs Strategy: Developing a comprehensive regulatory affairs strategy for medical device companies
โข Risk Management: Implementing risk management principles in medical device design, development, and manufacturing
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