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.

CyberActa medical device software design and development expertise minimizes vulnerabilities and reduces attack surface of every phase of the development cycle. BOSTON, MASSACHUSETTS, USA, January ...

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.

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.

“It is not a requirement for marketing such devices that the name of the device has been proved to correspond to what is actually happening,” Dr. Kevin J. Tracey, president and CEO of N… ...

Special Emphasis On Programmatic Efforts: One of the challenges in the original guidance document was not integrating it into existing medical device life cycle practices.The latest guidance ...

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 ...

The pilot version of the U.S. FDA’s advisory program for breakthrough medical device life cycle management was initially limited to cardiovascular devices, but the agency has announced an expansion ...

Gradient Denervation Technologies, a company that makes an ultrasound device for PH, will join an FDA program to speed device ...