Sequenex Renews ISO 13485:2016 Quality Management System Certification

Renewal strengthens Sequenex’s position as an integrated software product development partner for the medical device industry

ATLANTA--(BUSINESS WIRE)--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.

“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.

About Sequenex

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.