Medical Device and Pharmaceutical Product Development and Compliance

The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how design controls are evaluated during inspections. As the FDA aligns 21 CFR 820 with ISO 13485, inspectors will move beyond checking whether design control documents exist. Instead, they will assess whether design controls function as a connected, traceable system that integrates risk management, verification, validation, and change control. Below are five design control gaps the FDA will increasingly target under QMSR, and why many medical device companies may not be prepared.