His areas of experience include handling complex quality control operations, regulatory compliance, and leadership of large ...

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

SIGN Fracture Care, an FDA-registered and ISO 13485-certified medical device manufacturer, offers a good example of how to close the gap between quality control and the rest of the organization. As a ...

Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities ... containing "observations" that FDA inspectors "deem to be objectionable." ...

March 26, 2025 /PRNewswire/ -- Aveva Drug Delivery systems (A DifGen ... ZTlido®, DifGen aims to improve patient access to quality pain management options while also contributing to the ongoing ...

For two decades, pharmacists have been responding to an urgent need for more accessible healthcare. What began with ...

1 The National Medical Products Administration, in accordance with Article 310 of the Good Manufacturing Practice for Drugs ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...