WPI/MassMEDIC® Medical Device Certification Program

WPI and MassMEDIC have partnered to develop and deliver a certification program in Regulatory Affairs with the goals of increasing the level of knowledge of current medical device professionals and providing a pipeline of new potential employees. In addition, future certifications will be in the areas of Clinical affairs, Quality Assurance, Reimbursement, and Project Management. The Regulatory Affairs certification is intended to introduce basic regulatory affairs concepts to entry-level regulatory professionals or other medical device employees. This program will introduce students to the laws, regulations, and policies that are used to regulate the medical device industry. The students will also be exposed to the major elements a Regulatory Affairs professional would face, including submission strategies and FDA expectations. The course will concentrate on both domestic and international regulatory concepts.

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