With a document management system that can adapt to the unique way you work, while meeting the demands of regulated industry
Success in the medical device sector depends on the rigour of your processes, good operational governance, and rock solid design controls, But SMEs don't want to be restricted by needless bureaucracy. An adaptable, cloud based Document Management System can help define and drive an efficient but robust approach to med tech development, so that quality simply becomes 'the way you do things'.
Regulatory Submissions
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.
Software Validation
Cognidox helps you meet all the robust demands of software validation regulations required by ISO 13485 and 21 CFR Part 11
Then download this guide to get an in-depth exploration of a best practice approach to the medical device development process.
