Items Tagged with 'FDA'

With February 2026 now behind us, the FDA’s Quality Management System Regulation (QMSR) is here. For medical device manufacturers, the question has shifted from “are we ready?” to “can we demonstrate it?”

Integrated solutions combining ERP, MES, and QMS functionalities are replacing standalone QMS software in quality assurance. This shift enables real-time data collection and improved quality control. Medical device contract manufacturers can use these systems to enhance their quality services and gain a competitive advantage beyond cost and scrap reduction.

Kalpita Mehta is a combination products and medical device expert at a top U.S. generic manufacturer. She specializes in developing complex pharmaceutical products like COVID-19 testing kits.

Michelle Bangert, who is the managing editor of Quality, has a chat with Greg Weaver from Weaver NDT about additive manufacturing inspection.

FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.

In the medical device industry, success requires bringing innovative products to market faster than the competition.

Process validation is becoming ever more important within regulated and non-regulated industries.