Sequenex achieves ISO-13485:2016 certification
John Krlin of Sequenex
Sequenex, a digital health and medtech software development firm skilled in the diabetes and connected devices industries, announced it has received ISO 13485:2016 certification. This certification validates Sequenex’s commitment to delivering high-quality mobile, cloud and IoT software solutions.
ISO 13485, published by International Organisation for Standardisation, is an internationally recognised standard for the design, development, and manufacture of medical devices. By obtaining this certification, Sequenex has demonstrated that its quality management system (QMS) meets all applicable quality requirements and employs robust practices for the design and development of software as a medical device (SaMD). Certification in this vital area highlights Sequenex’s dedication to adhering to stringent quality standards and regulatory requirements, ensuring the safety 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,” says 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 and chronic conditions market in the future.”
Sequenex offers a range of services, including the development of mobile, cloud, and IoT SaMD/software solutions and software development kits (SDKs), personnels consulting, and dedicated software engineering teams and staff augmentation to ensure completion of client projects. With experience in developing diabetes and connected devices software solutions, Sequenex possesses the knowledge and capabilities to accelerate project completion, fill critical gaps, and assist clients in bringing their products to market.
By leveraging Sequenex’s quality management system and skills, clients can expect enhanced collaboration, reduced time to market, and optimal cost-efficiency in developing and launching their medtech and connected devices software projects. Sequenex’s future-proof products are built from the ground up for interoperability, integrations, and engagement, ensuring that clients stay at the forefront of technological advancements in the changing, interconnected healthcare industry.
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