ISO 14971 provides a framework for medical device manufacturers to identify and minimize risks through the design and manufacturing processes. Adhering to the standard helps ensure overall safety and ...

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 ...

In the wake of rising cases of medical device software defects and malfunctions, software quality assurance and compliance with regulation has come to the forefront of discussion among industry ...

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increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...

This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts that shows each of the ...