Sequenex Renews ISO 13485:2016 Quality Management System Certification

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Postmedia has not reviewed the content. by Business Wire Sequenex Renews ISO 13485:2016 Quality Management System CertificationAuthor of the article:THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountRenewal strengthens Sequenex’s position as an integrated software product development partner for the medical device industryATLANTA — Sequenex Corp. today announced the renewal of its ISO 13485:2016 quality management system certification. The certification is valid through July 9, 2029, and covers Sequenex’s quality management system for the “Design and Development of Software for use in Medical Devices.”ISO 13485:2016 is an internationally recognized quality management system standard for organizations involved in the design, development and manufacture of medical devices and related services.Sequenex first achieved ISO 13485:2016 certification in 2023 and has maintained its certification continuously. The renewal follows an independent assessment of the company’s quality management system and confirms its continued conformity with the requirements of the standard.Get the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try again“Medical device software requires more than working code,” said John Krlin, chief technology officer of Sequenex. “Requirements, risks, design decisions, changes and test evidence must remain connected throughout the software lifecycle. Our renewed certification reflects the quality management foundation that enables us to maintain that discipline.”Software increasingly shapes how medical devices connect, exchange data and support clinical workflows. Sequenex helps medical device companies address this need by combining specialized engineering, development under the controls of its ISO 13485-certified quality management system, and software lifecycle documentation designed to support customers’ Design History Files and regulatory activities.“Hardware-focused medical device companies need a software partner that understands the complete product—not simply an engineering vendor,” said Amy Neckermann, chief executive officer of Sequenex. “We bring engineering, quality processes and documentation together so customers can advance their software and device in parallel while reducing gaps, rework and development risk.”Sequenex works closely with customers and their quality teams to define the software lifecycle documentation appropriate to each program, which may include requirements, design documentation, risk management inputs, traceability, verification and validation evidence, and release documentation.Sequenex accelerates software delivery for connected medical devices, wearables, biosensors, CGM and SaMD through custom development, the NEX™ prebuilt software platform and medtech-focused engineering resourcing. Its ISO 13485-certified quality management system and software lifecycle documentation support help customers reduce development time, rework and risk from proof of concept through commercialization.For more information, visit https://sequenex.com.View source version on businesswire.com: This advertisement has not loaded yet.Notice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.