MDR technical file software for regulatory affairs

Project overview

Each device is a project with a six-step path: Device, Class, Evidence, Documents, Review and Ready. The overview shows where you are and the single next step that unblocks the dossier.

The assistant works alongside you and reports what it has done and what it could not find in your files.

• Progress per step, from facts collected to documents drafted
• Next step with the reason it matters
• Review queue and activity in one place

Device facts and MDR classification

Device facts are extracted from your documents and each one links back to its source. Facts the assistant cannot find become questions; facts that disagree are flagged for a choice.

Classification follows MDR 2017/745 Annex VIII: the rule and the exact clause are quoted, with the reasoning written into the classification rationale.

• Facts used across all documents: change once, see what needs a second look
• Annex VIII rule and clause quoted
• EUDAMED market data shown as a signal, never as an input

The dossier as Annex II folders

The technical file is organised in folders 00 to 10 that mirror MDR Annex II and III. Each folder shows its main document, evidence completeness, open decisions and status.

Labels can follow Annex II, BSI parts or your company format.

• Completion and status per folder
• Folders not applicable to the device stay visible with the reason
• "As submitted" view identical to the exported ZIP

Expected evidence, slot by slot

Each folder lists the evidence expected for your device, explained by its characteristics: for example sterilisation validation because the device is supplied sterile.

Drop files in bulk and Certifai proposes where each one belongs. You confirm.

• Filled, missing, not applicable with reason, or assigned to a colleague
• One file, many places: no duplicate revisions
• Approval status for each report

Documents with tracked AI proposals

The assistant drafts the main document of each folder from your evidence. When you ask for a change, it proposes it as a tracked change that you accept or reject.

The inspector shows where each paragraph comes from, the sources it cites, which documents cite it and its full history.

• Rewrite, Check against MDR, Explain on any selection
• Missing facts shown as questions, never invented
• Citations computed from what the AI actually read

Works on your own files

You do not have to rewrite what you already have. Certifai reads your Word, Excel and PDF files, cites them and proposes changes in place where the format allows it.

• Word: native tracked changes and comments, company style kept
• Excel: cell-level changes with the reason, formulas never overwritten (e.g. FMEA)
• PDF: signed evidence never modified; read, cited by page, annotated, inconsistencies flagged

One review queue

Everything waiting for a person sits in a single queue: questions, documents to update after a change, facts that disagree, proposed changes, missing evidence and AI-written text to review.

Every question explains why it is asked and which documents the answer will fill.

• Keyboard-driven: choose, answer, not applicable, later
• Answers become facts, then proposed changes you approve row by row
• AI-written fields marked until reviewed

Ready to submit

Before export, Certifai checks structure, references, evidence, approvals and open decisions. The checks inform, they never block: you can always export a draft.

The dossier is exported the way Notified Bodies ask for it, with your company branding.

• ZIP with the folder tree and one bookmarked PDF per folder
• Or a single Word or PDF file
• Drafts marked on the cover; every export recorded in the activity

Trust and transparency

AI augments regulatory experts, it never replaces them: the assistant proposes, people decide. Every change records who made it, what changed and when, human or AI.

AI-generated content is disclosed and marked in exports, in line with the transparency obligations of the EU AI Act (Art. 50). In the Notified Body view the AI only comments.

• Grounded writing and computed sources
• Draft → In review → Approved per document
• Full history and AI Act marking