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Human Factors Engineering for Medical Devices

Human Factors Engineering for Medical Devices

In February 2016, the FDA released a guidance entitled, “Applying Human Factors and Usability Engineering to Medical Devices.” The intention of this document, in combination with IEC 62366-1:2015 Part 1: Application of usability engineering to medical devices, is to...
Transitioning to ISO 13485:2016

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach....
What Happens When the FDA says, “I don’t know”

What Happens When the FDA says, “I don’t know”

The FDA is now trying to track what it’s calling “emerging safety signals.” Recently, a study found a possible link between reduced leaflet mobility in TAVRs and the incidence of stroke in the fall. When people turned to the FDA looking for insight, the agency...