Monthly Archives: April 2018

This is a series of blogs geared around accelerating product development through clinical study (animal, cadaver, or FIM). Successful medical device companies have been developing products for decades but along the way, some have developed quality systems no longer adequate to achieving competitive speed to market in the current landscape. There are many reasons for this: additions due to internal issues, embracing all FDA “suggestions” for improvement, general institutional scope creep inside the best-intended methodologies of creating safe, effective, and approvable medical devices   The results have yielded quality and…
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