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Trade Groups Taking Extra Steps To Ensure Start-Ups' Regulatory Know-How

AdvaMed and the Medical Device Manufacturers Association take steps to keep pace with a changing regulatory and policy environment for smaller device makers.

Device trade groups are funneling more resources into helping smaller firms navigate pre-market requirements as FDA, too, attends to smaller players.

An industry study last year found that smaller device firms have lower clearance rates and longer average review times than larger firms, and FDA has attributed some poor-quality submissions to...

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