The FDA has awarded breakthrough device designation to Hemex Health’s rapid diagnostic test for sickle cell disease and beta ...

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

As patient interest in regenerative medicine accelerates nationwide and regulatory scrutiny continues to intensify, Hyagen Medical, a regenerative medicine compliance and education company based in ...

Covestro displayed new medical devices using advanced polycarbonate materials for home healthcare and military applications.

Keeping up with the medical device world can feel like a lot. There are new regulations, cool tech popping up, and just ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Victoria-based company now has offices in Irvine, CA and Toronto, ON Many integrations fail, and I'm proud to say that ...

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...

Company and CoSara believe that ISO certification is a critical component of the regulatory requirements for clearance of new ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...

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 ...

Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre ...