Professional Certificate Medical Device Regulation
-- ViewingNowThe Professional Certificate in Medical Device Regulation is a crucial course for professionals seeking to navigate the complex regulatory landscape of the medical device industry. This program covers essential topics including regulations, quality systems, clinical trials, and post-market surveillance.
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โข Introduction to Medical Device Regulation: Overview of regulations, guidelines, and standards for medical devices
โข Medical Device Classification: Understanding device categories and their regulatory requirements
โข Quality Management Systems (QMS): Establishing and maintaining a QMS for medical device manufacturing
โข Design Control and Risk Management: Implementing design controls and managing risks in medical device development
โข Clinical Evaluation and Investigational Device Trials: Conducting clinical evaluations and trials for medical devices
โข Labeling, Instructions for Use, and Promotion: Ensuring compliant labeling, IFU, and promotion of medical devices
โข Post-Market Surveillance and Vigilance: Monitoring and reporting adverse events and product issues
โข Medical Device Regulation in Global Markets: Understanding international regulations and requirements
โข Regulatory Affairs and Submissions: Managing regulatory affairs and preparing regulatory submissions for medical devices
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