MED Institute not only adheres to medical device testing standards but also helps to set them, working with organizations such as the American Society for Testing and Materials (ASTM) to develop standards for medical and surgical materials and devices.
I’m Brian Choules, the director of nonclinical testing at MED Institute, and I serve on several standards committees; I’m also the chair for ASTM’s F04.30 cardiovascular standards committee. I get great enjoyment out of putting our practices into standards.
I’ve been extensively involved in writing test methods and contributing to standards since 2000 for ASTM as well as for the Association for the Advancement of Medical Instrumentation (AAMI), the American Society of Mechanical Engineers (ASME), and the International Organization for Standardization (ISO).
MED Institute’s involvement in setting standards benefits researchers and the industry—and it also benefits MED Institute. By helping to set these standards you get to lead and mold practices, but you also learn from others, so you keep up to date with the most advanced test methods.
Standardization is about coming to a consensus on the best way to do things. Sometimes fields are very new and no one really knows the best way to do things, so these standards are invaluable in setting a direction.
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