Complete Technical Documentation in One Calm Breath.

Cevvy uses artificial intelligence to accelerate document creation, while keeping you in full control. You decide whether to use AI or not. The system can suggest content based on your input, but every AI-generated element is transparent and fully editable. You decide what to keep. No hidden decisions, no black-box compliance. AI speeds your workflow, but your expertise drives the final documentation.

Don’t worry – cevvy is designed to be intuitive from the start. You don’t need training sessions or manuals. Most users feel comfortable within minutes and start building their first documentation structure in less than half an hour. And if you need a hand, we’re always here to help.

Yes. cevvy comes pre-validated as a configurable software system according to ISO/TR 80002-2. Your own validation for your intended use within your ISO 13485 quality system can be done directly in cevvy if you like, without any hassle.

Not yet – cevvy is currently focused on technical documentation. QMS support is in development and top priority on our roadmap. We're building it with the same logic-driven approach to make quality documentation just as smart and efficient. Coming soon!

Our servers are hosted by azure in Northern Europe to ensure high performance and data protection under EU law. The infrastructure is fully certified according to ISO 27001, ISO 27017, ISO 27018, and ISO 9001. Regular penetration and security tests are conducted by independent third parties. We’re currently finalizing our deployment setup and will publish full technical details soon.

cevvy comes with a full set of high-quality, MDR-compliant templates – no need to start from scratch. They’ve been tried and tested across many submissions and are continuously updated to reflect the latest regulatory expectations. Each template includes conditional content and pulls in data automatically, so you only see what’s relevant – and large parts of your documentation fill themselves out as you go. Everything stays customizable if you want to make changes.

You can export your technical documentation at any time with a single click – as structured, print-ready PDFs. Exports include your company logo, automatic cover pages, tables of contents, and consistent formatting, so they're ready to share with Notified Bodies or authorities without extra cleanup.

Notified Bodies aren’t allowed to perform formal reviews directly inside commercial tools – they still require PDF exports, which can be generated from cevvy at any time with one click. That said, read-only access for your Notified Body is already possible today. Feel free to nudge them to explore digital reviews – we’re ready when they are.

Most tools expect you to be a regulatory expert – or to work side by side with one just to build your technical documentation. cevvy takes a different path: it's the only tool that truly works with conditional content at its core. That means you don't need to know every detail of the regulations – and you can focus only on what's relevant for your product. No noise, no over-documentation, just the essentials.

cevvy is built on the MDKU data model – a structured, modular framework for technical documentation aligned with MDR. MDKU stands for Medical Device Knowledge Units and forms a standardized regulatory data model that ensures consistency not only within your company, but also with other stakeholders – worldwide.

That’s actually the beauty of cevvy – it works a bit like tax software for regulatory affairs. You answer structured questions, and cevvy takes care of translating your input into compliant documentation. Of course, regulatory know-how helps, but you don’t need to be an expert to get started.

It depends on how your current documentation is structured. If your TD is already in a digitalized single-source format, migration can take just a few hours. For more traditional setups, we guide you step by step – and offer smart import tools to make the process smoother.

Not yet – cevvy currently supports EU MDR (and IVDR coming soon). But managing multiple regulatory markets is top priority on our roadmap, and we're actively working on features for FDA, UKCA, and beyond. Stay tuned!

cevvy is the right tool for you if you want to move away from prose and start working with standardized input that can be processed automatically. It’s for teams who see documentation as data – and want to unlock automation, consistency, and reusability. cevvy is built specifically for small to mid-sized teams – including solo regulatory affairs professionals – who want to work faster without sacrifici.

We created cevvy because technical documentation for medical devices is often painful, messy, and unnecessarily repetitive. We wanted a tool that actually helps regulatory teams build compliant documentation faster without endless copy-paste or formatting chaos.