Professional Certificate in Medical Device Regulatory Intelligence and Analytics
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Intelligence and Analytics is a comprehensive course designed to empower learners with the necessary skills to navigate the complex regulatory landscape of the medical device industry. This program emphasizes the importance of up-to-date regulatory knowledge, critical for ensuring compliance and driving innovation.
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โข Understanding Medical Device Regulations: An overview of global medical device regulations, including FDA, EU MDR, and other international regulations
โข Regulatory Intelligence: Strategies for gathering, analyzing, and utilizing regulatory intelligence to inform medical device regulatory strategies
โข Regulatory Data Analytics: Techniques for leveraging data analytics to inform medical device regulatory decision-making
โข Medical Device Classification: Understanding the classification of medical devices and its impact on regulatory strategy
โข Regulatory Affairs Management: Best practices for managing regulatory affairs in the medical device industry
โข Clinical Trials and Regulatory Requirements: An examination of the regulatory requirements for medical device clinical trials
โข Medical Device Labeling and UDI: Understanding the regulatory requirements for medical device labeling and unique device identification (UDI)
โข Regulatory Submissions and Approvals: Processes and strategies for preparing and submitting medical device regulatory applications, including 510(k), PMA, and CE Mark
โข Post-Market Surveillance and Compliance: An overview of post-market surveillance and compliance requirements for medical devices, including reporting adverse events and maintaining compliance with ongoing regulatory requirements
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