Every medical device on the European market must be backed by evidence — continuously gathered, appraised and ready to defend in front of a notified body. VigInfo is where that evidence lives.

VigInfo is the system of record for a medical device's safety and clinical evidence under EU MDR 2017/745. Our platform turns scientific literature, incident data and your own documents into one explainable, audit-ready evidence base for clinical evaluation and post-market surveillance.

How it works:
• Ingest — from scientific and regulatory databases (PubMed, PMC, FDA MAUDE), uploaded documents, or free text
• Identify — explainable AI flags safety signals and clinical-performance evidence, each with a plain-language rationale. Never a black box.
• Review — human-in-the-loop by design: AI assists, your experts decide
• Record — every source, classification, rationale and decision captured in a complete, timestamped audit trail, with one-click access from any finding to the underlying source record

One continuous record feeds both pillars: the evidence foundation for your clinical evaluation report (Art. 61, Annex XIV) and ongoing surveillance — safety-signal monitoring, automated IMDRF coding and trend analysis for your PSUR and PMS reporting (Art. 83–90).

Built for everyone accountable for device safety: regulatory and quality teams at manufacturers, reviewers and auditors at notified bodies, and competent authorities overseeing the market.

Why VigInfo: MDR-native, not a generic review tool bent to fit. Explainable and human-led. Audit-ready end to end. EU-based, with EU AI Act use assessed as non-high-risk.

See it on your own device family — viginfo.eu

VigInfo AI

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VigInfo AI

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