Manufacturers
From 3,000 documents to a review-ready dossier.
ComplAi checks your technical file against the requirements before it reaches the notified body — so you fix gaps on your terms, not in a non-conformity round — and keeps it current as products, rules and markets change.
Thousands of documents, three rounds and a file that never stays finished.
The dossier is the bottleneck.
A technical file often runs to 2,000–3,000 documents. Compiling it and checking it against MDR or IVDR to an assessor’s standard is slow, manual and hard to do consistently.
Every non-conformity round costs months.
The quality of the file you submit decides how much comes back — and with a limit of three rounds, you cannot afford to find out late.
The file never stays finished.
Changes to products, suppliers and standards arrive weekly, and each new market brings slightly different rules.
How ComplAi gets your dossier review-ready — and keeps it there.
Pre-flight your technical file.
Completeness gaps, missing evidence-to-requirement links and the non-conformities an assessor is most likely to raise, ranked by impact and cited to the source passage. You fix them before you submit.
Works on its own — and with your notified body.
No need for your notified body to be on ComplAi. When it is, you work in the same secure data rooms.
Continuous compliance, ready for new markets.
Manage changes over time instead of rebuilding the dossier, and reuse it when you expand into markets with different rules.
Supplier and material evidence, collected at the source.
The technical file has to identify the suppliers and subcontractors involved in design and manufacture, and show what your materials contain — including CMR and endocrine-disrupting substances. ComplAi collects that evidence from each supplier in a shared data room and keeps it current, instead of chasing it for every submission. See Supplier assessment.
How the pre-flight check works
Connect
upload or sync your document store.
Ingest and classify
ComplAi classifies every document against the machine-readable requirements.
Pre-vet
completeness, evidence coverage and likely non-conformities.
Fix and submit
a prioritised, traceable report; resolve the gaps, then submit with confidence.
Certify once, then run every certificate from one place
The operating model behind the dossier also runs your whole management system: ISO 13485 and ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 42001, GDPR, CSRD/ESRS, and NIS2 for cyber security. ComplAi carries the manual and semi-automated ~60% of the work through recurring tasks, integrated ticketing and an MCP connector to your own AI assistants and agents.
Compliance cockpit · all management systems
- 5Due in 14 days
- 9Due in 30 days
- 21Later this year
- 46Complete
Due in the next 2 weeks
| Item | Standard | Deadline | Due |
|---|---|---|---|
| Calibration check: test equipment | ISO 13485 · §7.6 | Sun 18 Oct | in 2 days |
| Supplier questionnaire: resin supplier | ISO 13485 · §7.4 | Tue 20 Oct | in 4 days |
| Management review | ISO 13485 · §5.6 | Fri 23 Oct | in 7 days |
| Internal audit: design controls | ISO 13485 · §8.2.4 | Mon 26 Oct | in 10 days |
| Energy review | ISO 50001 · §6.3 | Thu 29 Oct | in 13 days |
Four pillars behind a review-ready dossier.
Accelerate
A cleaner submission and fewer clarification rounds.
Sustain
Keep the file and QMS current as things change.
Collaborate
Manufacturer or authorised representative and notified body in the same data rooms.
Prove
Every finding traceable to requirement and evidence.
ComplAi is the workspace DNV uses for all its medical device certification — built by people who know how assessment works.
- 9 of 11 non-conformities surfaced in a blind re-run of a file that had cleared notified body review
“In a blind re-run of a file that had already cleared notified body review, ComplAi surfaced 9 of the 11 non-conformities the assessor later raised.”
Frequently asked questions
Which regulations does the pre-flight check cover?
Any regulation, on request. ISO 27001 is ready to go; for EU MDR, IVDR or another standard, sign up for the pre-flight check, tell us which one you need, and we’ll set it up for you.
Why not use a general AI assistant?
It can summarise a document; it cannot assess a 3,000-document dossier the same way twice. ComplAi uses machine-readable requirements and cites every finding.
Does AI decide whether my file is compliant?
No. ComplAi prepares the analysis; your RA/QA team decides what to change, and the notified body makes the conformity decision.
Where is our data hosted?
All data is hosted in the EU. ComplAi is ISO 27001 certified and GDPR compliant.
See it on a file you already know.
Book a demo with your RA/QA team, or sign up for the pre-flight check and tell us which standard you need.