DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San ...

Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...

Dublin, Feb. 25, 2025 (GLOBE NEWSWIRE) -- The "What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained" training has been added to ResearchAndMarkets.com's offering.

Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...

But a new study published in the journal Production and Operations Management ... in drug safety. John Gray, co-author and professor at Ohio State University, said that regulatory and quality ...

The ISO 13485 standard is essential for ensuring the safety and effectiveness of medical devices and aligns with the recent U.S. FDA Quality Management System Regulation that harmonizes U.S. and ...