Certificate in Medical Device Regulatory Affairs Basics
-- ViewingNowThe Certificate in Medical Device Regulatory Affairs Basics is a comprehensive course designed to provide learners with a solid understanding of regulatory affairs in the medical device industry. This course is crucial in a time when regulatory compliance is more important than ever.
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GBP £ 140
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โข Medical Device Regulations: Overview of global medical device regulations, including FDA, EU MDR, and MDSAP
โข Quality Management Systems: Introduction to ISO 13485 and its role in medical device regulatory affairs
โข Clinical Evaluation and Trials: Understanding clinical data requirements, conducting clinical trials, and post-market clinical follow-up
โข Labeling and Packaging: Designing compliant labeling and packaging for medical devices
โข Medical Device Classification: Classifying medical devices based on risk levels and regulatory requirements
โข Registration and Listing: Processes and procedures for registering and listing medical devices with regulatory bodies
โข Vigilance and Post-Market Surveillance: Implementing systems for monitoring and reporting adverse events and ensuring post-market surveillance
โข Regulatory Audits and Inspections: Preparing for and managing regulatory audits and inspections
โข Medical Device Reporting: Understanding and complying with medical device reporting requirements
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