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Nitro cOS

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Nitro cOS is an AI compliance platform for medical device companies working under MDR, IVDR and FDA. It connects to the QMS and SharePoint you already use, tells engineers which documentation their work requires, drafts from your own documents, and maps which documents are affected when a regulation or product changes. A named reviewer approves every change. Built for QA, RA and R&D teams, Nitro cOS runs on top of existing systems with no migration, supports ISO 13485 and 21 CFR Part 11, hosts all data within the EU and never trains on customer data.

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