The medical device industry, alongside pharmaceuticals, is one of the most tightly regulated industries. In the interests of improving patient safety, medical device regulations are becoming more stringent in response to rapid technology innovation and the globalization of medical device manufacturing processes. Changing rules and regulations is a major concern for this industry, and business as usual for conformity assessment is not an option.
In response to the challenges described above, REASON-MD is a new digital solution for medical device manufacturers, their value chain and notified bodies for conformity management throughout the product life cycle.
REASON-MD combines advanced assessment features with predefined regulatory templates such as the new European Medical Device Regulation, that help MD manufacturers manage the conformity of their device nearly in real time. The already proven functionality of REASON-MD can bring up to 50% efficiency gain for conformity management.