Professional Certificate in Medical Device Regulatory Impact
-- ViewingNowThe Professional Certificate in Medical Device Regulatory Impact course is crucial for individuals seeking to understand and navigate the complex regulatory landscape of the medical device industry. This course covers essential topics such as global regulatory requirements, quality management systems, and clinical trial design, providing learners with a comprehensive understanding of regulatory expectations and compliance.
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⢠Regulatory Fundamentals: Understanding the regulatory landscape and frameworks for medical devices – FDA, EU MDR, MDSAP, etc.
⢠Regulatory Strategy: Developing a regulatory strategy for medical device product development and commercialization
⢠Quality Management Systems: Designing and implementing QMS for medical device companies (ISO 13485)
⢠Clinical Evaluation and Investigations: Conducting clinical evaluations and investigations to demonstrate safety and performance
⢠Labeling, Instructions for Use (IFU): Designing labeling and IFU to meet regulatory requirements and ensure safe use
⢠Post-Market Surveillance: Implementing post-market surveillance programs to monitor device performance and comply with regulatory reporting requirements
⢠Medical Device Reporting: Managing medical device reporting and adverse event reporting requirements
⢠Regulatory Compliance Audits: Conducting internal and external audits to ensure compliance with medical device regulations
⢠Regulatory Affairs Professional Development: Enhancing professional growth in regulatory affairs for medical devices
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