Published Articles
Why Early FDA Engagement Is Make-or-Break for Medical Device Startups
By: Claire Wallace, Senior Writer, Informa Markets – Engineering. Published by Medical Device and Diagnostic Industry Many device startups think they're ready for FDA submission—until they discover they lack documented...
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Published Articles
Navigating the QMSR Transition: Expert Insights on FDA Compliance, Risk Management, and Global Harmonization
By: Claire Wallace, Senior Writer, Informa Markets – Engineering. Published by Medical Device and Diagnostic Industry Regulatory affairs expert Jordan Elder breaks down the critical steps medical device manufacturers must...
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Published Articles
Designing a Test Plan that Works Globally: A Medtech Makers Q&A
As regional variations can create inconsistencies for testing a device, it’s important to work with a vendor that understands and can accommodate those differences. By Sean Fenske, Editor-in-Chief, Medical Product...
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Published Articles
Identifying Data Integrity Hotspots Using AI Technology
Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight in this publication from PharmTech....
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Published Articles
Digital Twins and the Future of Pharma Validation
Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks in this publication from PharmTech. Link...
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Published Articles
Why Robust Quality Systems Save Pharma Companies Millions
In this video article published by PharmTech, Susan Schniepp says poor quality in pharma manufacturing is costly but catching defects early can saves millions. Link to the Video and Article...
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