Global Certificate in MedTech Regulatory Affairs Essentials
-- ViewingNowThe Global Certificate in MedTech Regulatory Affairs Essentials is a comprehensive program designed to meet the growing demand for professionals with a deep understanding of regulatory affairs in the medical technology industry. This course emphasizes the importance of regulatory compliance, providing learners with a solid foundation in global regulations, quality systems, and clinical affairs.
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โข Global MedTech Regulatory Landscape: Understanding the international regulatory framework for medical devices, including FDA (USA), EU MDR, MDSAP, and others.
โข Regulatory Compliance and Quality Management: Implementing and maintaining compliance with regulations, standards, and quality management systems.
โข Clinical Evaluation and Investigational Planning: Designing and conducting clinical evaluations and investigations to support regulatory submissions.
โข Regulatory Submissions and Approvals: Preparing, submitting, and obtaining approvals for regulatory submissions, such as 510(k), PMA, and CE Mark.
โข Regulatory Affairs for Digital Health Technologies: Navigating the unique regulatory challenges and opportunities associated with digital health technologies.
โข Regulatory Post-Market Surveillance and Vigilance: Managing post-market surveillance and vigilance activities, including adverse event reporting and complaint handling.
โข Regulatory Labeling and Instructions for Use: Developing compliant and effective labeling and Instructions for Use (IFU) for medical devices.
โข Regulatory Affairs for Combination Products: Understanding the regulatory requirements and strategies for combination products, including drug-device and biologic-device combinations.
โข Regulatory Strategy and Life Cycle Management: Developing a comprehensive regulatory strategy and managing the regulatory life cycle of medical devices.
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