Advanced Certificate in Medical Device Regulatory Essentials
-- ViewingNowThe Advanced Certificate in Medical Device Regulatory Essentials is a comprehensive course designed to empower learners with critical skills in medical device regulatory affairs. This program is crucial in today's industry, where regulatory compliance is paramount.
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โข Medical Device Regulations Overview: Understanding the legal and regulatory framework for medical devices, including key players and regulations such as FDA, MDR, and IVDR.
โข Medical Device Classification: Learning how medical devices are classified based on risk and intended use, and the implications for regulatory strategy.
โข Quality System Requirements: Understanding the requirements for quality systems, including ISO 13485 and FDA QSR, and their impact on medical device design, manufacture, and distribution.
โข Clinical Evaluation and Testing: Exploring the clinical data requirements for medical devices, including clinical investigations, performance evaluations, and post-market surveillance.
โข Labeling and Instructions for Use: Learning how to create and maintain accurate, compliant labeling and instructions for use, including IFU, symbols, and warnings.
โข Medical Device Marketing and Advertising: Understanding the rules and regulations for marketing and advertising medical devices, including truthful and non-misleading claims.
โข Medical Device Vigilance and Reporting: Exploring the requirements for post-market surveillance, including adverse event reporting, vigilance, and recalls.
โข Regulatory Strategy and Submissions: Developing a comprehensive regulatory strategy, including preparing and submitting applications for market approval or clearance.
โข EU MDR and IVDR Transition Planning: Understanding the impact of the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation, and planning for the transition.
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