Nitro is an AI compliance platform for medtech companies. Getting a medical device to market means keeping thousands of documents in sync: requirements, risk analyses, test reports and technical files, across MDR, IVDR, FDA and ISO standards. Today that work happens in Word, Excel, email and the heads of a few experts. When one document changes, the rest have to follow, and gaps are often found too late, by an auditor. Nitro works on top of the QMS and SharePoint you already use. It maps how your documents connect, shows which requirements apply before work starts, flags what is affected when something changes, and drafts documentation from your own material. AI proposes, your experts approve. Built for regulated work: - Hosted in the EU - Your data is never used to train AI models - Role-based access and a full audit trail - Designed for 21 CFR Part 11, GDPR and ISO 13485 environments Nitro is built in Lund, Sweden, together with medtech companies piloting the platform, and is supported by LU Innovation.