OMTEC 2015: Design Verification Testing: What should you do when a testing standard doesn't exist?

Test methods are critical to success of design verification and validation. Many medical device industries (e.g., cardiovascular) have a limited number if standard test methods. At one point there were no ASTM or ISO standards related to cardiovascular stents. The fist two standards were published in 2001. Without standard test methods, patient risk, regulatory risk, and financial risk all increase.