Published Articles
Navigating the QMSR Transition: Expert Insights on FDA Compliance, Risk Management, and Global Harmonization
Navigating the FDA's Quality Management System Regulation (QMSR) The FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, aligns U.S. medical device quality system requirements more closely with ISO...
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Published Articles
Designing a Test Plan that Works Globally: A Medtech Makers Q&A
Developing a Strategic Medical Device Testing Plan A well-designed medical device testing plan is essential for demonstrating that a device is safe, effective, and performs as intended throughout its lifecycle....
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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
Data Integrity Hotspots As artificial intelligence and digital twins become more integrated into pharmaceutical manufacturing and validation, they are creating new opportunities to improve efficiency, strengthen quality oversight, and accelerate...
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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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