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Quality Managers | Moving from the Back Seat to the Driver's Seat in Medical Device Development project management quality management regulatory Dec 10, 2023

Written by Eric Sugalski

 

In many medical device organizations, the role of quality management is limited to reactive and compliance-focused activities. In these situations,...

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Dividing Lines between Design, Quality, and Regulatory Functions in MedTech design quality management regulatory Dec 02, 2023

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...

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EVT - It's like TSA precheck for Verification & Validation manufacturing project management quality management v&v May 02, 2023

Picture this -- you've raced to the airport and found yourself at the end of a massive security line. You do the truffle shuffle with shoes off, belt off, keys out, laptop out, while the security...

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Quality - The Secret Weapon to Accelerate Time-to-Market in Medtech product development quality management regulatory strategy Jul 06, 2022

Most of the time, quality (as in “quality management”) is only considered after a design concept is mature, if not finalized. Design control, document control, risk management –...

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