Executive Development Programme in Device Regulatory Essentials
-- ViewingNowThe Executive Development Programme in Device Regulatory Essentials is a certificate course designed to empower professionals with the necessary skills to navigate the complex landscape of medical device regulation. This programme is critical for career advancement in the medical device industry, where regulatory compliance is paramount.
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โข Regulatory Fundamentals: Overview of global device regulatory frameworks, key agencies, and regulations
โข Medical Device Classification: Understanding device categories, risk-based classification, and regulatory implications
โข Quality Management Systems: Design, implementation, and maintenance of QMS for device manufacture and regulatory compliance
โข Regulatory Strategy: Development of regulatory plans, timelines, and resources for device product lifecycle
โข Clinical Evaluation & Data Management: Principles and best practices for clinical data collection, analysis, and reporting
โข Labeling, Instructions for Use & Promotion: Compliant labeling, IFU, and promotional material development and review
โข Regulatory Submissions & Approvals: Preparation, submission, and maintenance of regulatory documentation
โข Post-Market Surveillance & Vigilance: Monitoring, reporting, and investigating adverse events, and product recalls
โข Global Harmonization & International Standards: Alignment with international standards, guidelines, and mutual recognition agreements
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