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FDA Human Factors for Medical Devices: Navigating the New Category 1, 2 & 3 Framework
OverviewFDA's 2026 Human Factors guidance has changed the way medical device manufacturers determin..
Date : 28th September 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 3 Hours
CAPA Under QMSR: Root Cause, Risk, and Effectiveness Verification
Overview: CAPA is one of the most closely examined parts of a medical device quality system, ..
Date : 23rd July 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit
Overview A medical device can undergo extensive biocompatibility testing and still encounter ..
Date : 16th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins
FDA Medical Device Cybersecurity in 2026: SBOMs, Threat Modeling and Submission Evidence
Overview A medical device manufacturer may have a software bill of materials, a completed thr..
Date : 27th November 2026
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 120 Mins