Focus on the patient, we'll handle the dossiers.
Your MDR technical file, built the way Notified Bodies read it.
Certifai Med classifies your device, organises evidence in Annex II folders and drafts every document with AI. Every sentence is traceable to your files, and nothing changes without your approval.
- MDR 2017/745
- Annex II/III structure
- Built in the Biomedical Valley, Mirandola (IT)
- EN/IT
Why MDR technical documentation is hard
Dossiers live in scattered files
Nobody tells you what's missing
AI text you can't trace is a liability
From device to submission: the six-step path
One guided path for every device, with a person deciding at every step.
Describe the device or drop its documents; the assistant extracts the facts and asks only what it can't find.
Describe the device or drop its documents; the assistant extracts the facts and asks only what it can't find.
The dossier as a Notified Body binder
Your MDR technical documentation is organised the way assessors open it, folder by folder.
- Folders 00–10 mirror MDR Annex II/III (labels also per BSI parts or your company format).
- One slot for every expected document: filled, missing, not applicable (with reason), or assigned to a colleague.
- One file, many places: a report used in 05, 06 and the GSPR exists once, no duplicate revisions.
- Drop many files at once: Certifai proposes where each goes; you confirm.
- "As submitted" view: what you see is exactly what goes into the ZIP.
The 11 folders of the MDR technical file
| Folder | Content |
|---|---|
| 00 | Index and summarySTED |
| 01 | Device description and specificationIncluding classification rationale |
| 02 | Information supplied by the manufacturerLabeling, IFU |
| 03 | Design and manufacturingDesign and production information |
| 04 | General safety and performance requirementsGSPR checklist |
| 05 | Benefit-risk and risk managementISO 14971 |
| 06 | Verification and validationPre-clinical tests, biocompatibility, sterilisation, packaging |
| 07 | Clinical evaluationCEP, CER, PMCF, SSCP |
| 08 | Post-market surveillancePMS plan, PSUR |
| 09 | EU Declaration of ConformityDoC |
| 10 | Substances and tissuesOnly if applicable |
Work in the document, with an assistant that proposes
The assistant drafts and suggests. You stay the author of record.
- Select a passage and ask: Rewrite, Check against MDR, Explain.
- The AI writes only as tracked changes; accept or reject each one.
- Click any paragraph: the inspector shows where it comes from (your files, deduced, draft), its sources, who cites it and its history.
- Missing facts appear as amber questions instead of invented text.
Works on your own files too
Keep the documents you already have. Certifai reads, cites and proposes changes in place.
Word
Native tracked changes and comments, your company style kept.
Excel
Cell-level changes with the reason, formulas never overwritten (e.g. FMEA).
Signed evidence is never modified: it is read, cited by page and annotated, and inconsistencies are flagged (e.g. IFU claims vs test report).
Trust by design
Explainability is the product: every sentence has an origin, a source and a reviewer.
Grounded writing
Facts come from your files; when something is missing the assistant asks.
Computed sources
Citations are calculated from what the AI actually read, never self-declared by the model.
Human review
Nothing enters the dossier without approval; Draft → In review → Approved per document.
Full history
Every change records who, what, when, human or AI.
EU AI Act transparency
AI-generated content is disclosed and marked in exports (Art. 50).
Notified Body impartiality
In the NB view the AI only comments, it never proposes text ("assessment support").
GDPR compliant and EU AI Act compliant. Security documentation and DPA available on request. Contact us
Why Certifai Med
Generate and analyze dossiers
Our specialized AI automatically analyzes your technical files, identifying regulatory gaps and suggesting improvements to ensure MDR/IVDR compliance.
Simplify the regulatory process
Automate technical documentation preparation and accelerate certification times, significantly reducing your team's workload.
Changes ripple, safely
Change a fact or the class once: Certifai flags every document that needs a second look and proposes the update. You decide.
Who it's for
RA teams at manufacturers
Build and maintain the MDR technical file for each device with one shared, traceable workspace.
Regulatory consultants
Manage several clients and devices with the same structure, review queue and export format.
Notified Bodies
Assessment support: completeness pre-screening and cross-document consistency, with an AI that only comments.
"Certifai Med reduced MDR preparation times by 53%."
Plans
Flexible solutions for every type of organization in the medical device sector
Pro
For individual RA professionals and consultants managing a few devices.
· 2 seats included
· 400 AI credits/month included
· Credit rollover for 1 month
Frequently asked questions
Bring one device. See your dossier take shape.
Book a demo and see how your technical file takes shape with Certifai Med.
Contact Us
Write to us by email or with the form below: tell us about your device and we will reply by email.
Let's talk about your project
Our team of experts in regulatory affairs and artificial intelligence is ready to help you optimize your certification processes.
Contact Information
Email: info@certifaimed.com