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.

Byron W. Larson

Specialties: Regulatory

Byron Larson is Founder and President of Toltec Ventures LLC Inc., a consulting company formed in 2015 specializing in medical device and combination product consulting, primarily in product development aspects.  Mr. Larson consults in technical and regulatory aspects of medical products.

Prior to the formation of Toltec Ventures, Mr. Larson was President and Co-Founder of Toltec International Inc. from 2001-2014.  Toltec International Inc. was a predecessor corporation to Toltec Ventures. Toltec International Inc. supplied services related to product development of medical devices and combination products for dozens of medical product projects.

A sample of consulting clients that Mr. Larson has engaged with at Toltec International and Toltec Ventures include Baxter, B Braun, Gambro Lundia, Gambro Dasco, SynCardia Systems, MicroMed Cardiovascular, Sewoon Medical, Kimberly Clark, Home Dialysis Plus, Fresenius Medical Care-NA, Curbell Electronics, KOS Pharmaceuticals, Transvivo, Viacyte, and Westmed.

Prior to co-founding Toltec International, Mr. Larson worked from 1986-2000 in various functions initially at COBE Laboratories Inc. which was later acquired by the Gambro Group.

Mr. Larson was head of the Research and Development department within the Gambro Renal Care Product’s US operations (2000). The primary responsibility was to lead a group responsible for technology transfer and support to 2 European sister facilities (one in Italy and the other in Sweden) during a reorganization of the US Operations.

At Gambro Renal Care from 1996-1999, Mr. Larson had overall engineering responsibility as the Lead System Engineer and Engineering Manager for a 35 member dialysis machine development project.  Project received 510k approval in 1998.  Mr. Larson also held roles as Engineering Manager, Quality Engineer, Manufacturing Engineer, and R&D Engineer at COBE Laboratories / Gambro Renal Care Inc. from 1986-1999.

Mr. Larson has earned degrees from Colorado State University (BSME) and the University of Colorado (MSME).  Mr. Larson is a certified Professional Engineer (State of Colorado, PE #27413), Certified Project Manager (Project Management Institute, PMP #18134, 1999-2002), and a Co-Inventor of 4 US and 2 International Patents.