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NAMSA建立于1967年，是全球医疗器械安全性和有效性研究领域中公认的先驱。早在美国FDA 1976年对医疗器械建立比较完整的监管法规之前，就在美国市场中为科学家对医疗器械安全性和有效性研究提供各种实验室测试研究服务。在全球医疗器械安全研究领域，NAMSA始终处于学术的最前沿。很多研究成果被全球标准组织采纳，作为各国医疗器械安全监管的基础。
NAMSA Started in 1967 by a PhD Biochemist/Physiologist who turned into 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.
每年全球有超过 3,000 家医疗设备和体外诊断公司信赖 NAMSA 帮助他们将创新的新产品推向市场或确保现有产品的持续安全性。我们拥有 1,400 名专家的团队随时准备帮助您进行市场研究、临床前研究、临床试验、生物安全测试、监管提交等。
Every year more than 3,000 medical devices and In Vitro Diagnostic companies worldwide trust NAMSA to help them bring innovative new products to market or ensure the ongoing safety of their existing products. Our team of 1,400 specialists are ready to help you conduct market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more.
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