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The Value of Obtaining Expert Advice Early On

This article was originally published in RAJ Devices

Executive Summary

By the time a typical medical device manufacturer contacts its certification body for compliance assessment, the design cycle has usually already ended. By this stage, critical components and subassemblies have already been purchased, launch dates have been scheduled, the 510(k), CE-marking documentation or equivalent technical files submission is in with the third party for review and there is little tolerance for design change.

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