Compile and publish your Design History File and other technical files at the touch of a button. Seamlessly manage regulatory submissions and audits required by ISO 13485, EU Notified Bodies and the FDA.
Rock solid change-control
Ensure your change control management is water-tight, with phase-gating and document approval processes built into the way you work and iterate your product.
Cognidox helps you meet all the robust demands of software validation regulations required by ISO 13485 and 21 CFR Part 11