Question
If you manufacture Class III medical devices, you've got a panic-inducing 71 days to comply with Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) guidelines. Are you ready? http://medgroup.biz/UDI-goes-in-ef...
At this year's 10x Medical Device Conference, Seth Goldenberg Ph.D., Senior Principal Scientist at NAMSA, gave an illustrative talk entitled, "Thinking Globally During Medical Device Development: Accelerating Products to International Markets." The f...
When you began your medical device company, you had an idea – and maybe a prototype, funding, and some customer interest. At what point did you start implementing a quality system? It's required to generate the product documentation for regulatory ap...
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A group member asks, "Does anyone have a ballpark figure in cost and timeline estimates for a third party to audit, assess, file and complete a class II 501(k) submission?" Steven Ziemba Exec. V.P. Quality, CLinical & Regulatory Affairs at Altaviz, L...
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