FRANKFURT, Germany--(BUSINESS WIRE)--NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, reimbursement and regulatory consulting services, is pleased to announce that it has been awarded DIN EN ISO/IEC 17025:2018 accreditation by DAkkS.
DAkkS, the sole national accreditation body for the Federal Republic of Germany, oversees ISO/IEC accreditation in the region, which is the single most important standard for testing laboratories around the world. ISO 17025 accredited facilities, which now include NAMSA’s state-of-the-art Analytical Services Laboratory in Obernburg, Germany, have demonstrated technical proficiency, as well as precise, accurate test data. (To see a full list of accredited testing types, please click here.)
“NAMSA is incredibly pleased to receive DIN EN ISO/IEC 17025:2018 accreditation. These proven test processes allow clients to minimize risk and ensure technical excellence as verified through a trusted, third party source,” commented Lisa Olson, Global Director of Analytical Services (NAMSA). She continued, “In today’s medical device regulatory climate, ISO 17025 accredited test results are critical in demonstrating quality data to increase the likelihood of accelerated regulatory authority reviews and approvals. We look forward to providing clients ISO 17025:2018 services, in addition to continuing to deliver ISO 10993-18 (chemical characterization) testing in Europe.”
The pioneer of the medical device testing industry, NAMSA provides clients the benefit of strong working relationships with EU regulatory entities, including the EU Commission and Notified Bodies, as well as a demonstrated track record of delivering significant time and cost savings throughout the development continuum.
NAMSA’s Obernburg, Germany Analytical Services Laboratory represents the organization’s fourth European location and its growing investment in Europe’s largest medical device market and commitment to providing closer client collaboration through a centrally-located development partner.
NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical research, reimbursement and regulatory consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements anywhere in the world.
NAMSA operates 13 offices throughout Asia, Europe and North America, and employs over 1,000 highly-experienced laboratory, clinical research and consulting Associates.