Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has successfully passed the GMP on-site inspection by South Korea's Ministry of Food and Drug Safety (MFDS) with ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Any company looking to work with a CDMO should begin by defining its own product’s development requirements. For example, a ...

Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...

DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response.

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

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities in San ...

Symbiosis’ completion of the FDA regulatory review is expected to increase the company’s commercial-scale sterile manufacturing capabilities.

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

along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby modules covering various aspects of the company’s products are submitted ...

Monogram, which has previously obtained FDA clearance for its mPress implants, is seeking 510(k) clearance for its robotic products. The company is committed to developing a multi-application robotic ...