ISO-13485:2016 Certification Granted to Sequenex

Sequenex has achieved ISO 13485 certification for its quality management system. The certification validates Sequenex’s commitment to delivering high-quality software solutions and reinforces its position as a trusted partner in the healthcare technology sector, according to the company.
 
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 practices for reviewing and validating its product development pathways. ISO certification in this 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,” Sequenex Co-Founder/Chief Technology Officer John Krlin said. “With this ISO 13485 certification, we further solidify our position as a reliable provider of SaMD solutions for the diabetes and connected devices markets. We are proud of the Sequenex team for working hard to gain this certification and we look forward to providing our services to a broader medtech market in the future.”
 
Sequenex offers a 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. 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.

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.