Working closely with risk analysis teams helps UX designers consider various use conditions that may not be immediately obvious during the design phase.

Tens of millions of Americans live with medical devices implanted in their ... whose stories are told in this report. As for the smaller number of high-risk products for which advance safety ...

The Society for Healthcare Epidemiology of America (SHEA), in collaboration with eight partner organizations, has released ...

such as ISO 13485 (medical device quality management) and ISO 14971 (medical device risk management), require ongoing updates to security protocols, adding another layer of complexity. In ...

Supply chain risks and asset management remain key areas in need of improvement among healthcare’s cybersecurity efforts, ...

With disruptions to operational continuity and patient care delivery being key concerns, the report focused on a specific combination of medical device ... management-based approach to risk ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...