Compliance Corner: 5 Tips For Successful FDA Inspections, From SOPs To Roleplaying
Four industry experts – including a Medtronic quality VP and two former FDA investigators – offer advice on how device manufacturers can better ensure smooth sailing during an FDA audit.
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Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.
The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.
The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.