Elevated Human Factors for Medical Devices with Ron Kaye
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Medical Device Human Factors for Risk Control, Usability Validation & ISO-62366 compliance.Elevated theory for effective application to Usability Validation of medical devices and real world usability.
Ron Kaye recently retired from the FDA’s Center for Devices and Radiological Health where he led the development of its Human Factors initiative during his 19 year tenure at the agency. Ron was the lead author of the original FDA human factors guidance released in 2000, and the current HF guidance released in February 2016, which represents the perspective of the FDA on pre-market submission human factors requirements. During his time at CDRH, Ron participated in over 1000 new device reviews involving human factors work submitted to almost all CDRH divisions, has trained FDA CDRH and CDER HF reviewers and (some) field inspectors, and has participated in Agency post-market responses and recalls associated with use error issues.
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Elevated Human Factors for Medical Devices with Ron Kaye
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