OVERVIEW

Medical Device Development Immersion Course 2021 is organized by Biotech Primer, Inc and will be held from Nov 03 - 04, 2021.

Who should attend:
Anyone who works in medicine, engineering, finance, legal, marketing, business development, project management, IT, administrative support, quality assurance, regulatory affairs, and manufacturing.

Description:
This 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.

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.

Additional details will be posted as soon as information is available.