Some med tech eQMS options are clunky and prescriptive. They can force you to change the way you work just to match their software's defined processes. They can tie you up for months with unnecessary complexity.
Find a solution that is adaptable, scalable, and designed to flex with your needs. With Cognidox, document control, workflow automation, compliant e-signatures and software validation come as standard. And if you already have a certified QMS in place, we'll minimise the process changes you'll need to make to adopt the platform.
Cognidox is a document management system designed for complex product development with a lean approach to design controls and quality compliance. We have a proven track record of helping innovative companies scale and succeed.
Meet the requirements of FDA 21 CFR 11, FDA 21 CFR 820, ISO 13485 and the MHRA GXP guidelines. Compile and publish your Design History File and other technical files at the touch of a button.
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 FDA 21 CFR 11.