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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Blogs
FDA’s 12‑Digit NDC Update: What Drug Manufacturers Need to Know Now
The FDA is transitioning the National Drug Code to a standardized 12‑digit format, with the final rule taking effect on March 7, 2033. While the timeline may seem distant, this...
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White Papers
Human Factors Engineering for Medical Devices
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to reduce use errors and ensure medical devices are safe and effective for their...
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