BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
11/03/2021 - 11/04/2021 | 10:00 AM - 4:30 PM EDT
Medical Device Development Immersion
Medical Device Development Immersion is an interactive, two-day preparatory course designed for those who need to better understand all aspects of medical device development. Beginning with an overview of the medical device industry, the course quickly delves into the changing regulatory environment and the different regulatory pathways devices can undertake for FDA or EMA marketing approval. Attention is then focused on a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course ends with a brief look at commercialization, including reimbursement strategies. Learn from an industry expert with 30-years of experience in both large and start-up medical device companies.
BIO members receive a $100 discount. BIO members should use the code BIO100 to register for this course.
Takeaways
- Fluency in the essential terminology and acronyms used in the medical device sector.
- Improved communication with engineers, regulators, colleagues, and clients.
- Ability to construct a medical device by following the traditional five phases of development.
- Understanding of the medical device approval pathways in both the USA and European Union.
- Conduct risk mitigation during medical device development.
Download Course Syllabus
Certificate Requirements
- Attend the entire live master course
Learn how to develop and gain regulatory approval for medical devices.
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