Started in 1967 by a PhD Biochemist/Physiologist who turned in to an entrepreneur, NAMSA was the first independent company in the world to focus solely on testing medical device materials and pharmaceutical containers for safety. In fact, NAMSA started testing medical devices before the U.S. Food and Drug Administration starting regulating such products in 1976.
We weren't just the start of a new business, we were the beginning of an industry.
At the time, medical device regulations were few and test methods were being adopted from the pharmaceutical industry and other compendia. The late 1900s brought increased regulations in the form of Good Laboratory Practices and ISO standards for worldwide acceptance of test methods for biocompatibility and sterilization. Today, regulations abound in the U.S., Europe, Japan and other industrialized nations with differing levels of sophistication and product approval processes. NAMSA has been a key contributor to the development of test methods that govern our industry in the 1970’s, 1980’s, 1990’s and even today. In fact, many NAMSA scientists actively participate in domestic and international standard setting committees to help shape the future of test methods to assure adequate consideration for patient safety and rapid product development timelines. Learn more about NAMSA's corporate values.
