Tuesday, October 8, 2019–FRANKFURT, Germany–(BUSINESS WIRE)–NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, and 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 for the following:
- DIN EN ISO 10993-1: 2010-04: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- DIN EN ISO 10993-12: 2012-10 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
- DIN EN ISO 10993-18: 2009-08 Biological evaluation of medical devices—Part 18: Chemical characterization of materials
- FDA Guidance use of ISO 10993-1: 2016-06 Use of International Standard ISO 10993-1, “Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process,” Guidance for Industry and Food and Drug Administration Staff
- GNQS-TM-00001: Determination of extractable non-volatile organic substances (UPLC-MS)
- GNQS-TM-00002: Determination of extractable volatile organic compounds (GC-MS)
- NFLS-TM-00001: Determination of extractable elements by ICP-MS
- NFLS-TM-00008: Exhaustive Extraction
- NFLS-TM-00009: Material characterization using FTIR
- NFLS-TM-00010: Determination of extractable semi-volatile organic compounds by gas chromatography mass spectrometry (GC-MS)
- USP 40 <621> Chromatography
- USP 40 <197> Spectrophotometric Identification Tests
“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, German Analytical Services Laboratory represents the organization’s fourth European location and its growing investment in Europe’s largest medical device market, as well as its commitment to provide closer client collaboration through a centrally-located development partner.