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GenPrime achieves transition to ISO 13485:2016 registration months before international requirement.

SPOKANE, Washington – August 2018 – GenPrime is pleased to announce that it has achieved official recommendation for an upgrade to certification for ISO 13485:2016 by BSI Group America. ISO 13485 is the international standard for medical device quality management systems and has recently been updated from its 2003 standard to include enhanced requirements such as risk-based decision making. GenPrime’s holistic approach to quality has enabled its seamless transition to adopt the updated standard months before it becomes required by BSI on February 28th, 2019.

GenPrime first received its certification for ISO 13485 in 2010 and has maintained its certificate through annual third-party audits. Prior to when the company began selling its Point-of-Care Test Reader for drugs of abuse testing throughout Europe, GenPrime strove to demonstrate quality management system conformance throughout its full scope of operations. The ISO certification then laid the groundwork for the company’s subsequent 510k-approval and resulting opportunity to sell the xReader™ within the United States. This process requires ongoing compliance to the U. S Food & Drug Administration’s Quality System Regulations in Code of Federal Regulations – Title 21 – Food and Drugs , which include good manufacturing practices not unlike those of ISO 13485. Section 820 in particular identifies the Quality System Regulations as they pertain to good manufacturing practices (CGMPs) for finished medical devices. Therefore, it is critical that GenPrime always prioritizes maintaining an adherence to only the most current standards.

GenPrime constantly evolves to maintain its quality system by:

  • Giving team members individual responsibility for improvements in their areas of expertise,
  • Working with experienced external consultants to gain insightful outside perspective, and
  • Fostering a teamwork-oriented culture that results in collaborative approaches to solutions.

GenPrime has proven that it can navigate whatever regulatory hurdles may appear within its path. This resilience, combined with a steadfast foundation and dedicated team, poises GenPrime to expand its medical device product offerings through multiple applications and regulatory arenas. In turn, this will lead to greater market exposure and offerings, enabling the company to ultimately achieve its mission to provide “innovations for a secure and healthy world.”


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Authors: Jacob Masters, Market Analyst at GenPrime, Inc.; Claire Norton, Quality Assurance Manager at GenPrime, Inc.

For title mage source and more information on BSI Group America's ISO 13485, click here

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