eQMS for SaMD Companies | Agile Medical Device QMS | Orthogonal
222 W Merchandise Mart Plaza #228, Chicago, IL 60654
(312) 374-6490
https://maps.app.goo.gl/KqJjFDewKpFXk63P7
https://orthogonal.io/eqms-for-samd/
Reduce the cost of compliance at Agile speeds with Orthogonal’s eQMS for SaMD companies. Our electronic Quality Management System (eQMS) is built on Jira and Confluence – tools development teams already use – to automate design controls, risk management, and traceability. Features include automated traceability matrices, ISO 14971-compliant risk analysis, Part 11-compliant signatures, and dynamic documentation that updates as requirements change. By integrating ALM and PLM directly into familiar tools, our eQMS reduces the cost and duration of design control activities by 25–50%, enabling faster releases without compromising regulatory compliance. Perfect for SaMD and connected medical device teams seeking an Agile, audit-ready QMS. Contact Orthogonal to tailor our eQMS to your product and team needs.