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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Blogs
FDA Form 483 Response Guidance Update
In this brief expert walkthrough, we review the FDA’s latest guidance on responding to Form 483 observations and highlight what has changed and what it means for your organization. An...
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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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Visual Resources
Contamination Control Strategy (CCS) Services
Inspection‑Ready Contamination Control. Built for FDA & EU Annex 1. A strong Contamination Control Strategy (CCS) is essential for protecting patient safety and meeting today’s regulatory expectations. Regulatory Compliance Associates®...
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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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