The system of record for a device's safety and clinical evidence.

VigInfo turns literature, incident data and your own documents into one explainable, audit-ready evidence base under EU MDR.

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VigInfo dashboard for a PGA surgical suture: counts of articles analysed, awaiting review, reviewed, serious incidents and auto-excluded, above charts of articles found over time by source and by text availability.

If an auditor reviewed how device evidence is managed today, the findings would write themselves.

Finding 01

Evidence is fragmented

Literature databases, incident registries, internal documents. The evidence for one device lives in many places, and nowhere as a whole.

Open

Finding 02

Screening is manual and repeated

Expert reviewers screen, appraise and code by hand, then do it all again at the next surveillance cycle or CER update.

Open

Finding 03

Decisions are hard to reconstruct

When a notified body asks why an article was included, excluded or flagged, the reasoning lives in someone's memory, not in a record.

Open

Resolution

One continuous, explainable, audit-ready evidence record. That is what VigInfo is built to be.

VigInfo

The platform

One evidence base. Every deliverable.

VigInfo ingests evidence from any source, uses explainable AI to identify what matters, keeps a person in every decision, and holds the authoritative record behind your clinical evaluation and post-market surveillance.

01 / Ingest

From any source

Pull from scientific and regulatory databases such as PubMed, PubMed Central and FDA MAUDE, upload your own PDFs, or paste free text. Structured or unstructured, no fixed forms.

02 / Identify

Explainable AI

VigInfo reads each item and flags safety signals and clinical performance evidence, each with a plain language rationale. Never a black box.

03 / Review

Human in the loop

Nothing is decided automatically. Your experts confirm, adjust or reject every finding. VigInfo assists the decision; a person makes it.

04 / Record

Audit-ready by design

Every source, classification, rationale and reviewer action is captured in a complete, timestamped audit trail a notified body can follow end to end.

What it covers

From clinical evaluation to ongoing surveillance, and back.

Clinical evaluation and post-market surveillance draw on the same body of evidence. VigInfo maintains it as one continuous record, so what surveillance finds tomorrow updates what your evaluation concluded yesterday.

Clinical evaluation

The evidence foundation for your CER

Systematic, documented literature identification and appraisal: the evidence base your clinical evaluation report is built on, with the methodology laid open for review.

Documented searches with transparent inclusion and exclusion
Clinical performance evidence flagged and appraised
Every judgement traceable to its source

MDR Art. 61 / Annex XIV

Post-market surveillance

Continuous safety signal monitoring

Ongoing vigilance across literature and incident data, surfacing signals as they emerge and keeping your surveillance reporting fed with current, defensible evidence.

Safety signals identified and prioritised, with rationale
Automated IMDRF coding of incidents across all annexes
Trend analysis feeding PSUR and PMS reports

MDR Art. 83 to 90 / IMDRF

One record, both directions

Why VigInfo

Not a literature tool. A regulatory record.

Generic review tools run one-off projects. VigInfo is built around the regulation itself, as a continuous, explainable record designed for how notified bodies actually assess evidence.

Explainable and human-led

Every finding, justified

Each classification carries a plain language rationale and a human decision. The reviewer sees the device, the event, the clinical signs and the assigned IMDRF codes as one connected graph before confirming anything.

VigInfo document review screen: a connected graph linking a medical event to the device, device problem, component, patient, clinical sign and health impact, each carrying an IMDRF code, beside a review progress panel and article summary.

Audit-ready

Traceable end to end

A complete chain from source to conclusion. The same record your reviewers, your notified body and an auditor can all follow.

MDR-native

Built around the regulation

Designed for EU MDR clinical evaluation and post-market surveillance from the first line, not a general purpose tool bent to fit.

Source-agnostic

Whatever the origin, one evidence base

Scientific databases, incident registries, your own documents or free text. Everything lands in the same reviewable set, with source, database, article type and device relevance on every row.

VigInfo documents list: 182 documents for a device, each row showing title, type, article type, database, source, date, device relevance, safety signal and clinical effect, with search and filters.

Built for everyone accountable for device safety.

The same traceable evidence base serves the manufacturers who compile it, the notified bodies who review it, and the authorities who oversee the market.

Manufacturers