MD&M East

FDA Warns of Potential Problems with Some NuVasive MAGEC System Components

FDA alerted patients, caregivers, and providers of potential mechanical failures and biocompatibility concerns associated with components of several NuVasive's MAGEC devices, which are intended for ...
JD Supra

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

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 ...
Becker's ASC

Polymicro Technologies Achieves FDA Quality System Regulation Registration, Compliance

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...
JD Supra

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...