Use Cognidox to record, store and index every document from ideation through to release and upgrade. Then publish your Design History File at the ‘touch of a button’.
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.
Then download this guide to get an in-depth exploration of a best practice approach to the medical device development process.
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