The Device Is Done
When the Paperwork Is Done.

We use AI to accelerate the most time-consuming parts of document creation — generating structured first drafts of protocols, pulling regulatory clause mappings, creating traceability matrix frameworks, and drafting risk assessment tables. An expert engineer then reviews every output for technical accuracy and regulatory defensibility before anything is finalized or delivered to you. The analogy is a senior engineer with a very fast junior — the speed is real, the quality bar is unchanged.

No — what matters to regulators is the technical content and whether the document demonstrates compliance with applicable requirements. FDA and Notified Bodies don't evaluate how a document was drafted; they evaluate whether it is accurate, complete, and defensible. Our process ensures every document meets that bar. AI is a tool for speed and consistency — the regulatory expertise that validates each output is entirely human.

We start with a rapid gap assessment — typically 3–5 days — that maps every element of your existing DHF against 21 CFR 820.30 and ISO 13485 requirements and produces a prioritized remediation list. From there we work through the gaps systematically, reconstructing missing documentation from existing engineering artifacts (CAD files, test data, emails, meeting notes) wherever possible, and creating new documentation where records don't exist. The goal is a DHF that will survive an FDA inspection or Notified Body audit.

This is exactly where our model shines. Because we have a global engineering network on call, we can rapidly scale the team working on your documentation when the timeline demands it. Time zones work in your favor — documents drafted overnight in one region are reviewed and refined the next morning in another. If you have a specific deadline — an FDA submission, a Notified Body audit, a customer requirement — tell us the date and we'll work backward from it.

Yes — this is a common engagement. Companies that launched products before having robust documentation in place, or that are now targeting new markets (EU MDR, Health Canada, etc.) that require more complete technical documentation than their original FDA submission, come to us to build or upgrade their technical file. We reconstruct design history, build risk files, write clinical evaluation reports, and produce every document needed for a new market submission or a legacy product remediation.