Developing a medical device has always been a complex process. Manufacturers must continue to drive innovation while facing ever-intensifying business challenges, including the onslaught of fierce competition, the difficulty of managing globally dispersed teams, and an increasing need to address quality and risk. On top of this already challenging state of affairs, OEMs must also comply with strict and ever-changing regulatory requirements imposed by governing agencies around the globe.
So how does a medical device manufacturer navigate this balance beam at high speed?
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