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Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 25th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971
Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..
Date : 27th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 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