Find the missing evidence before your notified body does.

A fixed-price review of one device's technical documentation. We match each applicable Annex II and Annex III requirement to the document, page and passage that supports it, and mark what we could not find. Your RA/QA lead makes every call.

Request a review See a specimen matrix

For RA and QA leads at medical device manufacturers · Mapped to EU MDR Annexes II and III · UK MDR or FDA files: ask before sending · €2,500 fixed, one device · Not a certification or regulatory advice

Accuracy record

Not yet published for technical files. Until it is, every flagged row is reviewed by a person before delivery.

RegulationUnder EU MDR Article 10(4), manufacturers must draw up and keep up to date technical documentation that allows the device's conformity to be assessed, including the elements set out in Annexes II and III. Great Britain's UK MDR 2002 sets its own requirements, based on the earlier EU directives. In the US, the FDA's QMSR, in force since 2 February 2026, incorporates ISO 13485:2016.Source: Regulation (EU) 2017/745, Art. 10(4), Annexes II–III; UK Medical Devices Regulations 2002 (SI 2002/618); FDA 21 CFR Part 820 (QMSR) (checked 2026-09-25)

EXAMPLES

DocumentsDevice description · GSPR checklist · risk file · CER · PMS plan

Items3 example requirements

AnswersCited to your file, or marked not found

EXAMPLE 01

You ask: Where does the file state the intended purpose, intended users and patient population?
You get: The passage, with the document, revision and page it came from — or “not in evidence” if nothing you sent states it.
From: Annex II, section 1.1

EXAMPLE 02

You ask: Does every line of the GSPR checklist point to a document that actually says what the checklist claims?
You get: Each GSPR line beside the passage it cites, with any line whose reference does not hold up flagged for your reviewer.
From: Annex II, section 4

EXAMPLE 03

You ask: Is there a post-market surveillance plan, and what does it say about how data is collected and reviewed?
You get: The plan's own wording, cited to its page, or a plain “not in evidence”.
From: Annex III

See a specimen matrix How the benchmark works

Where the weeks go

The GSPR checklist is only as good as its references: Every line points to a document. Somebody has to open each one and confirm it still says what the checklist claims — after every revision of every document it cites.
Deficiency questions arrive in rounds: Each round sends someone back through the file, looking for evidence that was there all along, or finding out that it was never written down.
The file was written by people who have moved on: Technical documentation outlives the team that wrote it. The evidence is usually in there. Knowing which document, which revision and which page is what left with them.
Most assessment hours go on finding, not judging: A gap assessment is expert judgement sitting on top of a very long search. The search is the part we take off your team; the judgement stays with them.

What comes back: the evidence matrix

One row per requirement. Every row names the document, revision and page, quotes the passage, and says what it is: found, not in evidence, or a question only your reviewer can answer.

SpecimenFictional Class IIa wound dressing · fictional documents · not a customer's file

RequirementEvidencePassageStatusFor your reviewer

Annex II §1.1Intended purpose, intended users and patient populationEvidenceDevice Description DD‑001 · Rev C · p. 3Passage“…intended for the management of moderately to heavily exuding partial-thickness wounds in adult patients, applied by healthcare professionals.”FOUNDFor your reviewerNone.

Annex II §4GSPR 10.4.1 — CMR or endocrine-disrupting substances above 0.1% w/wEvidenceGSPR Checklist GC‑002 · Rev B · p. 14; Biological Evaluation Report BER‑004 · Rev A · p. 12PassageChecklist: “Not applicable.” BER‑004: “…adhesive layer contains a phthalate plasticiser…”FOR REVIEWERFor your reviewerThe checklist and BER‑004 disagree. Confirm whether 10.4.1 applies to the adhesive layer.

Annex II §5Benefit-risk conclusionEvidenceRisk Management File RMF‑010 · Rev B · p. 41Passage“The overall residual risk is judged acceptable when weighed against the clinical benefits described in CER‑2025.”FOUNDFor your reviewerNone.

Annex II §6Sterilisation validationEvidenceNothing in the documents sentPassageDD‑001 p. 5 says the device is sterilised by ethylene oxide. No validation report was among the documents sent.NOT IN EVIDENCEFor your reviewerDoes a validation report exist outside this set? If so, add it and we re-run the row.

Annex III §1Post-market surveillance plan — how data is collected and reviewedEvidencePMS Plan PMS‑003 · Rev A · p. 2Passage“Complaint and vigilance data are reviewed quarterly by the PMS team and trended against the risk file.”FOUNDFor your reviewerNone.

A real matrix covers every section of Annex II and Annex III that applies to your device. These five rows show the three things a row can say.

What you send, what you get back

You send

The technical documentation for one device, as you would give it to your notified body — PDF, Word or Excel
Your GSPR checklist, if you keep one
The current revision of each document, and nothing superseded

You get back

The evidence matrix, as a spreadsheet and a PDF
A list of every requirement marked “not in evidence”
A list of questions for your reviewer, one per flagged row
Every citation checked against its source page, and every flagged or “not in evidence” row reviewed by a person, before it reaches you

One price, agreed before you send anything

Evidence review

€2,500 fixed, per device

For a manufacturer preparing one device's file for its notified body.

One device, one technical documentation set
Every applicable Annex II and III requirement
Matrix as spreadsheet and PDF
Scope and date agreed before you send anything

Request a review

For QA/RA consultancies

Per client ask us

For consultants who run gap assessments across several manufacturers.

The first-pass matrix for each client's file
You review it and deliver it under your name
Each client in its own isolated workspace

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What it is not

It is not a certification, and it is not regulatory advice: You get a map of where your evidence is and where we could not find it. Whether the file meets the requirement is your qualified person's call, and the notified body's. Nothing here stands in for either.
“Not in evidence” means not in what you sent: It never means the evidence does not exist. It means it was not in the documents we were given. Add the missing document and the row is re-run.
It won't tell you which revision is current: Send current revisions only. Every row records the document and revision it came from, so a superseded file is visible in the matrix rather than silently cited.
It is a deliverable, not part of your quality system: The matrix is a working document for your team to review, the way a consultant's gap assessment is. It does not replace your eQMS or your document control, and it is not a validated system.
We have not yet published our accuracy on technical files: Our published tests cover other kinds of documents, so they are not evidence for yours. That is why flagged rows are reviewed by a person today. With your agreement, we keep a de-identified record of each review decision — accepted, corrected or rejected, never your documents — and publish our accuracy on technical files as it is measured. You can say no, and the review is the same.
English-language documents only: The review is tuned for English. Ask before sending a file in another language.

Request a review

Tell us the device. We reply with the scope and a date. Nothing is sent, and nothing is owed, until both are agreed.

Tell us the device and its class
We agree the scope, the date and what we may keep before you send anything
You upload into a private workspace for your company alone
You receive the matrix, and your RA/QA lead decides what it means

Tell us about the device

We reply with the scope and a date. A person reads every request.

SureCiteAI's evidence review is a document search and cross-referencing service. It is not a conformity assessment, not a notified-body opinion and not regulatory or legal advice. Every determination about the conformity of a device rests with the manufacturer and its notified body. The matrix shown on this page is a specimen built from a fictional device and fictional documents.