Sequenex Corp., a software developer that builds applications for connected medical devices and continuous glucose monitors through its NEX platform, renewed its ISO 13485:2016 quality management system certification. The accreditation, which remains valid through July 9, 2029, covers the company's internal protocols for the “Design and Development of Software for use in Medical Devices.” Independent auditors completed the assessment to verify conformity with the international standard, continuing a certification status the vendor first achieved in 2023.
The ISO 13485 standard governs the engineering and manufacture of medical hardware alongside related clinical services. As medical workflows depend on connected systems to exchange data, hardware manufacturers require software engineering processes that align with regulatory mandates. Sequenex produces software lifecycle documentation, including risk management inputs and validation evidence, to support the Design History Files required by its clients.
“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.”
“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.”
Alongside custom engineering, the company provides staffing resources and prebuilt components for Software as a Medical Device products. The quality management system framework allows clients to define the specific release documentation and verification materials needed to move their programs from initial proof of concept to commercialization.
