WPI, MassMEDIC Partner to Offer New Regulatory Training Program for Employees of Medical Device Companies

New Certificate Program Designed to Meet Unique Workforce Development Needs of Medical Device Companies
March 09, 2011

Worcester Polytechnic Institute (WPI) and MassMEDIC are launching a new Medical Device Certificate Program to help people working in the industry expand their skills and stay current with evolving best-practices and federal regulations.

The new program will be offered in Waltham, Mass., beginning April 12 with a certification course covering "Regulatory Affairs." This first course will introduce students to the laws, regulations, and policies that govern the medical device industry, including submission strategies and FDA expectations. The course will concentrate on both domestic and international regulatory concepts.  

"We are excited to partner with WPI to offer this important program," said Thomas J. Sommer, president of MassMEDIC, which represents 375 medical device and associated companies in the region. "WPI is a leader in the field of continuing and supplementary education, and our members value the access to this high level of expertise and training to help their employees develop, and thereby help their companies succeed."

The Medical Device Certificate Program includes five eight-week courses, with classes meeting one night per week to accommodate students' work schedules. The courses will cover regulatory affairs, clinical research, quality assurance, reimbursement, and project management associated with medical device development.

 "We are focusing on these five modules because that's what the companies have told us are the critical knowledge areas for their employees," said Rachel Yamartino, associate director of the WPI Corporate and Professional Education division (CPE). "One of the hallmarks of our approach at WPI is to be closely attuned to the needs of the industries we partner with."

The certificate program curriculum is designed primarily for people who have experience working in medical device companies, but can also be beneficial for new-hires who have some related experience and need to come up to speed on medical device industry practices. The program is structured so that individuals can choose the areas of study that are most relevant to them, or take on all five modules. Upon successful completion of any one module, as measured by a final exam, participants will receive individual certification in that module. Those who successfully complete all five modules will receive a Medical Device Certificate from WPI and MassMEDIC.

Classes will be held at the DoubleTree Suites Hotel in Waltham, Mass. For more information about the program contact Amanda Maurer Keighly at 508-831-4179 or maurer@wpi.edu.

About MassMEDIC

The Massachusetts Medical Device Industry Council (MassMEDIC) is the voluntary grassroots association of medical device manufacturers and associated companies in the Commonwealth. MassMEDIC is the only organization in New England dedicated solely to promoting the unique interests of the medical device industry. For more information see www.massmedic.com