The first technical file is due
You're CE marking under MDR and want to know what's required before the work starts, not during review.
Nitro fits when…
The US is on the map
FDA requirements need handling alongside MDR, without writing the documentation twice.
Documents start from zero
The team writes in Word and Excel with no context from earlier documents, and generic AI tools give nothing back.
A regulation is being updated
You want to know which documents are affected the same day, not after weeks of manual mapping.
Find the requirements before the audit does.
An operating system on top of what you already have. The right documentation from the start, drafts with your context, and a map of what's affected when something changes.