SaMD Diabetes Software Experts

Sequenex Achieves ISO 13485 Certification for its Quality Management System

FOR IMMEDIATE RELEASE: Sequenex announces it has received ISO 13485 certification for its quality management system.

SAN DIEGO – Sequenex, a leading software development firm specializing in the diabetes and connected device industry, is proud to announce it has received ISO 13485 certification for its quality management system. This important certification validates Sequenex’s commitment to delivering high-quality software solutions and reinforces its position as a trusted partner in the healthcare technology sector.

ISO 13485 is an internationally recognized standard for the design, development, and manufacture of medical devices published by the International Organization for Standardization. By obtaining this certification, Sequenex has demonstrated that its quality management system (QMS) meets all applicable quality requirements and employs robust practices for the review and validation of its product development pathways. ISO certification in this vital area highlights Sequenex’s dedication to adhering to stringent quality standards and regulatory requirements, ensuring the safety and effectiveness of its products and services.

“We are known for our expertise in rapidly designing and developing software systems that are purpose-built for innovation, connectivity, and interoperability,” said John Krlin, Co-Founder and CTO of Sequenex. “With this ISO 13485 certification, we further solidify our position as a reliable provider of cutting-edge SaMD solutions for the diabetes and connected devices markets.  We are really proud of the entire Sequenex team for working so hard to gain this certification and we look forward to providing our services to a broader medtech market in the future.”

Sequenex offers a comprehensive range of services, including the development of mobile, cloud, and IoT SaMD solutions, expert consulting, and dedicated teams and staff augmentation to ensure the successful completion of client projects. With extensive experience in developing diabetes and connected devices software, Sequenex possesses the knowledge and capabilities to accelerate project completion, fill critical gaps, and assist clients in bringing their products to market quickly and efficiently.

By leveraging Sequenex’s quality management system and expertise, clients can expect enhanced collaboration, reduced time to market, and optimal cost-efficiency in developing and launching their diabetes and connected devices software projects.. Sequenex’s future-proof products are built from the ground up for interoperability, integrations, and engagement, ensuring their clients stay at the forefront of technological advancements in the healthcare industry.

About Sequenex

Sequenex is a platform and product development company specializing in the diabetes and connected device industry. With a focus on innovation, connectivity, and interoperability, Sequenex works with medical technology companies to design, develop, and sustain software systems that empower healthcare providers and patients. The company offers expert consulting services, staff augmentation, and dedicated teams to accelerate project completion and deliver high-quality Diabetes and connected device SaMD solutions. For more information, visit


Amy Neckermann

VP Business Development

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