This multi-day workshop, from MassMEDIC and Biotech Primer, will help you onboard employees new to medtech with a step-by-step guide to the basics of medical device development. Classes will be held over multiple days.
Medical Device Development Immersion is a ten-hour course that surveys all aspects of medical device development. Learn about the changing regulatory environment and compare the United States and European Union approval processes. Discover in detail the five phases of medical device development: market opportunity, evaluation, design, verification, and manufacturing. Take this course to develop an understanding of the entire process required to bring a new medical device to market.
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.
What you'll get from attending the class:
-Improved ability to communicate with engineers, colleagues, regulators and manufacturers
-Fluency in medical device terminology, acronyms, and processes
-In depth understanding of the five steps used in medical device development
-Regulatory criteria to determine if a product is a Class I, Class II, Class III medical device