WASHINGTON, D.C. — On Monday, the FDA’s Center for Devices and Radiological Health (CDRH) announced the continued expansion of its Total Product Life Cycle (TPLC) Advisory Program. This ...

To manage this risk, clinical device life cycle management is crucial. But the traditional method has gaps, including manual tracking with spreadsheets and paper, and capturing information on ...

By Dhanaraj PN For medical device manufacturers, 10 years is an ideal life span of a product. However, devices typically remain in active usage for as long as 20 years.

For example, IEC 62304 Medical Device Software — Software Life Cycle Processes is an international standard that provides a framework for developing and maintaining SaMD and software within ...

Medical devices often have a long life cycle, and many run on outdated and unsupported operating systems, lacking the capability to update to a newer version.

Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program ...

Headquartered at Fort Detrick, Maryland, AMLC is the Army’s Life Cycle Management Command for medical materiel, with the ILSC serving as the tip of that sustainment support spear.