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proactive quality management medical device development

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, quality managers primar...

design quality regulatory dividing lines

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 regula...

5 steps for an early and informative q-sub with FDA

5 Steps to Prepare for an Early and Informative Q-Sub with FDA regulatory May 18, 2023

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 feedbac...

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