The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).

This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge of the audit process. Auditing is a ...

FDA is cracking down on medical device cybersecurity. In response to an increase in healthcare cybersecurity threats, prevalence of connected devices, and pressure from the United States Government ...