Design Validation, Verification, and Risk Analysis for Medical Device Professionals

This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to V&V and Risk Analysis and the FDA's supplemental guidelines. An ISO perspective is offered to compliment the FDA view.

Among the topics to be discussed are: Context of V&V and Risk Analysis within the overall quality system and regulation, V&V and Risk analysis procedures, V&V methodologies, V&V strategies, types of risk analysis, risk mitigation, and methods to determine probability and severity for Risk analysis.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Byron W. Larson is President of Toltec Inc., a consulting firm specializing in medical-device product development and consulting. He has worked in the medical-device industry for nearly 30 years.

Prior to the formation of Toltec, Mr. Larson was responsible for US Research and Development operations for Gambro Renal Care Products.

Mr. Larson earned his BSME from Colorado State University and his MSME from the University of Colorado. Mr. Larson is certified by the State of Colorado as a Professional Engineer and by the Project Management Institute as a Certified Project Manager.

Mr. Larson is an inventor and co-holder of four United States and two international patents.