Sequenex becomes ISO-13485:2016 compliant


The renowned MedTech and digital health software development company Sequenex, with a focus on linked devices and diabetes, is pleased to announce that it has obtained ISO 13485:2016 accreditation. The achievement of this significant accreditation attests to Sequenex’s dedication to providing premium cloud, mobile, and Internet of Things software solutions.

The International Organization for Standardization publishes ISO 13485, a globally accepted standard for the creation, development, and production of medical devices. By receiving this certification, Sequenex has proven that it uses strong practices for the design and development of Software as a Medical Device (SaMD) and that its quality management system (QMS) satisfies all relevant quality criteria. Being certified in this crucial field demonstrates Sequenex’s commitment to upholding strict quality standards and legal obligations, guaranteeing the efficacy and safety of its goods 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 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 provides a wide range of services to guarantee the successful completion of client projects, such as developing Software Development Kits (SDKs), mobile, cloud, and IoT SaMD/software solutions, professional consulting, and specialized software engineering teams and staff augmentation. Having developed software solutions for connected devices and diabetes for a long time, Sequenex has the know-how and resources to close gaps in projects, expedite project completion, and help clients launch products with speed and efficiency.

Clients may anticipate improved communication, shortened time to market, and maximum cost-efficiency when creating and implementing their software projects for MedTech and connected devices by utilizing Sequenex’s quality management system and experience. Future-proof systems from Sequenex are designed from the ground up with interoperability, integrations, and engagement in mind. This guarantees that customers stay ahead of technology breakthroughs in the ever-evolving, globally networked healthcare sector.



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