Dividing Lines between Design, Quality, and Regulatory Functions in MedTech
Dec 02, 2023
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Written by Eric Sugalski
In the complex world of medical device development, one area that often causes confusion is understanding the division of responsibilities between design, quality, and...
5 Steps to Prepare for an Early and Informative Q-Sub with FDA
May 18, 2023
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Many organizations believe that the Q-Sub process should be completed after a design is relatively mature. The belief is that sufficient technical detail needs to be shared to gain substantive...
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