BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Medical Device Approval Primer
Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements and different medical device classifications, from Class I to III, that are critical to ensuring patient safety. This primer provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA. Learn about the importance of Quality System Regulations (QSR) requirements, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) used worldwide in medical device development. Become fluent in assessing risk and choosing the appropriate medical device approval pathway. grab your seat today!
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Takeaways
- Identify the medical device industry's major device sectors and worldwide regulatory
organizations. - Classify medical devices based on potential risks.
- Explain the major medical device approval pathways.
- Discuss how the Code of Federal Regulations and Good Practices enforces regulatory compliance.
- Develop a risk management plan for a medical device.
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Certificate Requirements
Complete the course quiz with a passing score of 75% or higher