Way back in 2001, MD+DI published an article detailing what the author considered to be The Seven Deadly Sins of Medical Device Development. The author reviewed dozens of device development programs ...

I clearly remember standing in the operating room (OR). I was there with our sales representative to observe a case as part of our normal Voice of Customer (VOC) process. I had seen well over 50 ...

VOLTAS, a medical device development manufacturing company, opens its new facility built to support medical device ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

Why is it necessary to develop human resources for developing medical devices? Muragaki: Medical devices tend to be over-imported, with data for 2021 showing a trade deficit of 1.8 trillion yen. In ...

The "Playbook for Threat Modeling Medical Devices" was commissioned by the FDA and co-developed by MITRE and MDIC. The Food and Drug Administration on Tuesday announced the release of a new playbook ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

Medical device innovations have enhanced healthcare and improved patient care, but they present a broad attack surface for healthcare organizations. NetSPI, a security service company, hosted medical ...