OMTEC 2015 Speaker Presentations

Technical Seminar: Design Verification Testing

Often, devices are novel such that standardized test methods (e.g., ISO, ASTM) needed to adequately assess the device do not exist. What should you do? This session will offer strategies and best practices to help ensure that an adequate safety assessment of the device and acceptance of the new methodology by regulatory bodies takes place when confronted with this situation.

Session Takeaways
  • Strategy and best practices for establishing a new non-standardized test methodology for use in design verification and validation
Who Should Attend
  • Research & Development
  • Regulatory Affairs

Brian Choules, Ph.D., is the Director of Testing at MED Institute and has been involved with ASTM, AAMI, ASME and ISO standards development for 13 years. Specifically, Dr. Choules has been an active participant in development of standards regarding vascular stents, stent-grafts, IVC filters, corrosion, MRI safety and computational methods verification and validation. Dr. Choules has been integral to engineering teams in the development of numerous Class III devices, including the specification of design requirements and building of test plans. He has also supported teams obtaining regulatory approval from worldwide regulatory bodies of various medical devices. He earned a mechanical engineering degree from Brigham Young University and post-graduate mechanical engineering degrees from Purdue University, where he researched ceramic coatings.