Paradigm Perception Shift in Medical Device Development: The INNOVATION ROADMAP

There is a common perception in the industry that medical regulatory design controls and risk management (i.e. FDA-QSR & ISO-13485) are often viewed as a mandate, a process that will inhibit innovation.  The perception shift is in using these processes and the FDA’s guidance as a viable medical device development innovation/commercialization platform given a properly outlined INNOVATION ROADMAP. Watch here