Medical device development has moved to a model where regulatory compliance functions as a primary technical constraint. Engineering teams must treat global frameworks as specifications that dictate ...

Understand cGMP requirements for portable environmental monitoring to support contamination control in pharmaceutical cleanrooms.

On February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) became effective and enforceable. After a two-year ...

HALIFAX, NS, April 8, 2026 /PRNewswire/ - ABK Biomedical, Inc. and COR Development are proud to announce a strategic partnership to develop a state-of-the-art GMP manufacturing facility in Cartwright ...

Medline (Nasdaq:MDLN) has received a warning letter from the FDA related to NAMIC brand angiographic control syringes and ...

The United Nations’ World Health Organization projects a shortfall of approximately 11 million health workers by 2030. As ...

SpectronRx secures $85M from OrbiMed to expand medical isotope production, boosting radiopharmaceutical manufacturing and ...

This investment was made by LOTTE HOLDINGS Healthcare & Biopharmaceutical Corporate Venture Capital (HB‑CVC), an investment arm of LOTTE HOLDINGS, and will further strengthen Rakuten Medical’s ...

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...

This intensive symposium covers the 2026 pharmaceutical and medical device landscape, focusing on global supply chain ...

Starting today, some App Store apps must declare whether they are regulated medical devices in the US, UK, and Europe. Here are the details. According to a new blog post on Apple’s Developer blog, ...

App Store product pages will now display whether an app is a regulated medical device, Apple said today. The designation will be shown in the ‌App Store‌ in the European Economic Area (EEA), United ...