How Gaps in Requirements Traceability Fuel Recalls and Injuries
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
As the volume of IoT-enabled machines in healthcare explodes, so do the number of cybersecurity threats.
What can HTM professionals do about preventing or mitigating use error in medical devices? To find some answers, 24x7 reached out to experts on the topic.
Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.
We’ve tried complaining. We’ve tried educating. What else can we do about medical device user errors? Plenty!
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