FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
Medical Device Network on MSN
The medical device manufacturing crunch
With Covid accelerating time-to-market for medical devices, digital tools play a key role in managing converging priorities for device manufacturers.
Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important milestone in the Company's continued ability to provide cell therapy medical ...
PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...
Enlil and Interlynk join forces to transform SBOMs into dynamic tools for managing cybersecurity in medical devices.
Lightweight portable system delivers fast, precise, objective data for rapid aid in diagnosis of concussions in ...
13d
Enlil and Interlynk Partner to Close the Cybersecurity Gap for SaMD and Connected Medical Devices
The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...
The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- The global health consciousness is increasing, and ...
DONGGUAN, GUANGDONG, CHINA, January 15, 2026 /EINPresswire.com/ -- As global healthcare regulations tighten and patient ...
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