FAQ
Questions we get.
- Is Nitro an eQMS?
- No. Nitro cOS runs on top of your existing QMS, SharePoint and document templates. It does not replace your QMS or change your processes.
- Which regulations does Nitro cover?
- MDR (EU 2017/745), IVDR (EU 2017/746), FDA 21 CFR 820 (QMSR), 510(k), De Novo and PMA, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, 21 CFR Part 11 and the EU AI Act, among others.
- Does Nitro replace our QMS or SharePoint?
- No. Nitro reads your documents where they already are. Nothing is migrated or moved.
- Is our data used to train models?
- Never. Your documents, specs and policies are not used to train any model, ours or anyone else's.
- Where is data hosted?
- On servers within the EU. Data never leaves the EU, not even for backups.
- How long does setup take?
- Days, not a project. We set up the connection to your QMS and SharePoint together with your QA lead.
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.