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 Overview & Regulation
Medical Device Overview and Regulation explores the diversity of the medical device industry by highlighting its various sectors, top companies and major regulatory bodies worldwide. Device classification and each classification’s differing approval pathways are outlined in detail. The course concludes with a look at the quality system regulations and risk management plans you must follow. If you are new to medical device, Medical Device Overview and Regulation will provide an understanding of the industry’s regulatory breadth
Takeaways
- Identify the major sectors, worldwide regulatory organizations and top companies of the medical device industry.
- Classify medical devices based on potential risk.
- Explain the major medical device approval pathways.
- Discuss how the Code of Federal Regulations and Good Practices enforce regulatory compliance.
- Develop a risk management plan for a medical device.
Download Course Syllabus
Certificate Requirements
- View the entire course
- Pass course exam with a 70 percent
- Complete course evaluation
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