by Peter Rizzo, Manager of Positive Customer Relations
At Medical Development Group Boston’s (MDG Boston) May 4th forum, representatives from Winchester Engineering Analytical Center (WEAC) presented information on their specific roles and helped clarify WEAC’s relationship as a support facility for the FDA. WEAC provides front-line data collection and analysis, as well as post-market performance investigation for medical devices and more. Faced with a crowd of medical device industry professionals, agents of the FDA can expect a wide array of questions and comments covering many subjects. The team from WEAC represented the FDA exceptionally, emphasizing their role in supporting and providing front-line expertise for OEMs and service providers for medical devices and laser devices.
Medical device manufacturers must commit to regulatory compliance and embrace the role of the FDA in enforcing the rules. WEAC is a laboratory overseen by and supporting the mission of the FDA in post-market surveillance of medical devices and other technologies, including lasers and devices with a radioactive footprint. The duties of the engineers and scientists at WEAC include analyzing the safety and performance of medical devices and radiation-emitting equipment in the marketplace.
In recent months MDG has experienced rapid growth, and has continuously sought to improve and enhance their program offerings. Peter Madras, President of MDG, has been successful in recruiting new attendees and members, as well as sponsors, which Cogmedix is proud to be. Cogmedix proudly supports efforts to educate and promote regulatory compliance. As we say every day: Cogmedix = Compliance!