Turn complex medical device regulations into step-by-step, audit-ready workflows. Built for SaMD and AI device teams navigating UKCA, EU MDR, and FDA.
Start at the dashboard and select or create a dedicated workspace for your device. Each workspace is isolated, so your data stays where it belongs.
Use Document Wizards to input data step by step. AI Assist provides real-time hazard suggestions and input feedback, while Guidance Panels explain what each step requires and why.
Hazards, clinical inputs, and intended use captured once flow automatically across risk, evidence, and PMS modules, keeping every part of the file consistent without manual reconciliation.
The platform updates traceability links between hazards, controls, and verification as documentation evolves. Post-market monitoring runs continuously in the background.
AI triages adverse events and the trend analysis engine monitors signals and severity escalations, so periodic reporting is grounded in live evidence rather than a manual sweep.
Accept, decline, or refine AI suggestions at every stage. Nothing progresses without your review and sign-off. Outputs remain under human control from first input to final export.
Reduce time-to-market without compromising compliance. Regi operationalises compliance at every stage of your regulatory journey, from initial concept, through launch, and beyond.
Requirements become step-by-step workflows with plain-language guidance at each step. Capture inputs once and outputs stay consistent as the product evolves.
Device workspaces covering pre-market, post-market, traceability, and multi-jurisdiction compliance. Document Wizards guide creation of PMS plans, clinical evaluations, and risk files.
Produce consistent, defensible artefacts across UKCA, EU MDR/IVDR and FDA. Every output keeps a traceable thread from intent to evidence.
Walk through the full assessment flow — from intended purpose to classification, pathway map, and a regulator-ready report, all generated from your inputs.
Define your device's intended purpose with structured guidance. AI Assist flags clinical context, patient population, and use-condition gaps in real time as you type. Wording shapes classification, and Regi shows you how.
Your intended purpose statement is assessed across UKCA, EU MDR, and FDA simultaneously. Classification results appear instantly, with the exact rule applied and a plain-language explanation for each jurisdiction.
A complete market entry roadmap for each jurisdiction, derived automatically from your classification. Every requirement is listed with its current status (done, in progress, or to do), so nothing is missed.
A structured, regulator-ready report generated from your inputs. Every classification decision is linked and traceable. Export and maintain it alongside your QMS, with no copy-paste and no manual formatting.
Define your device's intended purpose with structured guidance. AI Assist flags clinical context, patient population, and use-condition gaps in real time as you type. Wording shapes classification, and Regi shows you how.
Regi isn't your QMS or RIM. It's the execution layer that turns fragmented regulatory expectations into step-by-step, auditable workflows, so teams produce review-ready outputs and run consistent pre-market and post-market operations as the product evolves.
Capture inputs once, then keep outputs consistent and up to date as the product changes. No duplicated effort, no stale docs.
Use Regi for early framing and submission readiness, then stay on top of post-market work without starting over.
Regi shows what evidence is needed, why it matters, and how assessors are likely to evaluate it. AI-generated search protocols for literature reviews give you a structured starting point, with human-in-the-loop editing before anything is finalised.
Every output keeps a traceable thread from intended purpose, risks and controls, to evidence and PMS. Reviews are quicker; documentation is easier to defend.
Regi's AI Assist suggests potential hazards, gives contextual feedback on your inputs, and grounds recommendations in applicable guidelines, legislation, and your internal data. It flags gaps, contradictions, and drift. You review, approve, and sign off.
Treat UKCA, EU MDR/IVDR and FDA as one evidence problem with tailored outputs for each. Reuse core work when expanding markets or releasing new versions.
AI-powered adverse event triage and a trend analysis engine monitor signal strength and severity across your post-market data, so periodic reporting is grounded in live evidence rather than a manual sweep.
The Traceability Hub and built-in Essential Requirements Matrix (GSPR) link every identified hazard to its risk controls and verification evidence, giving reviewers and auditors a complete, defensible thread from intended purpose to proof.
Regi provides a structured support system to help you approach regulated markets with confidence. Auditable, defensible intelligence prevents common mistakes.
Regi creates repeatable regulatory execution with built-in rationale capture and traceability, improving consistency and audit posture across a portfolio.
Deliver consistent, audit-ready client artefacts faster, with embedded explainability and clean handover, without losing editorial control.
Still not sure? Get in touch and we'll walk you through the platform.
Talk to usWhether you're a startup entering regulated markets for the first time or a multi-product team looking for operational consistency, Regi is built for you.