Meet Regi.
Your intelligent co-pilot for regulatory compliance.
Don’t let regulation become a barrier. Reduce time-to-market for AI and SaMD devices without compromising compliance.
Define your product’s classification, intended purpose and evidence generation plan.
Generate PMS plans and a coherent evidence narrative across multiple markets.
Address changing regulation and higher risk classifications as you scale and your product evolves.
Compliance made simple.
Regi supports you at every stage of your regulatory journey - from initial concept, through launch - and beyond.
Build exactly what you need for compliance and classification across the full product lifecycle with an AI-enabled guide and expert knowledge.
Navigate the regulatory requirements across EU-MDR, UKCA, FDA, and document everything required - especially as your product changes and grows.
Document, manage and monitor device context, connected data sources, risks, reporting, monitoring, governance and security so you’re not rebuilding documentation from scratch every time things change.
How Regi works
Step 1: Pick your market and pathway
Tell Regi where you’re selling (UKCA, EU MDR/IVDR, FDA) so it knows the rules you need to meet.
Step 3: Turn your requirements
into a plan
Regi’s execution logic assists you to classify your device; optimize and tailor your intended use statements for the market and risk level, and converts your context into a clear evidence and PMS plan.
What sets Regi apart?
Regi doesn’t replace your QMS or RIM. It’s the execution layer that turns fragmented regulatory expectations into step-by-step, auditable workflows so teams can produce review-ready outputs and run consistent pre-market and post-market regulatory operations as the product evolves.
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Regi turns regulatory requirements into step-by-step workflows you can actually run so compliance isn’t a one-off document exercise. Teams capture the right inputs once and generate consistent, review-ready outputs as the product changes.
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Regi supports early regulatory framing through to post-market operations, including structured PMS planning, event intake/triage, and periodic reporting. It helps you maintain a single evidence narrative from pre-market assumptions into post-market reality.
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Regi guides teams on what evidence is required and why. This reduces ambiguity and prevents late-stage rework caused by missing justification or weak linkage.
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Every output is backed by traceable rationale that connects intended purpose, claims, risks, controls, and evidence. That means faster internal review and stronger defensibility under audit or regulator scrutiny.
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AI is used to flag gaps, contradictions, and missing rationale, and to help draft content based on your inputs and support decisions. Final outputs stay under human control with defined review and sign-off.
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Regi doesn’t replace QMS/RIM platforms, it complements them by producing structured, consistent artefacts that fit your existing stack. Think of it as the layer that turns live product context into regulator-ready execution.
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Regi treats UKCA, EU MDR/IVDR, and FDA expectations as one evidence challenge with framework-specific outputs. You avoid rebuilding from scratch when you expand markets or update claims.
Who uses Regi?
Regi is built for teams who need speed without regulatory shortcuts.
Startups
Get regulator-grade structure without slowing down
Move faster with explainable reasoning, clear evidence requirements, and exportable outputs without reinventing templates every sprint.
Scaling portfolios
Standardise evidence across products and markets
Create repeatable evidence logic and consistent outputs that feed QMS/RIM downstream, reducing fragmentation across the portfolio.
AI/SaMD
Build an evidence strategy that evolves with your product.
Regi links intended use, claims and risk to evidence requirements, and maintains continuity as versions, models and datasets change.
Step 2: Describe your product (fast)
Drop in the essentials: draft intended use, users, key claims, data/AI basics - just enough to anchor everything else.
Step 4: Run guided workflows.
Work through bite-sized steps for risk, governance, monitoring, and reporting - Regi keeps everything linked and consistent.
Step 5: Export audit-ready outputs.
Generate regulator-ready documents and artefacts that plug into your QMS/RIM, then keep them up to date as your product evolves
Life sciences
Add evidence intelligence to your regulatory stack
Regi complements existing infrastructure by improving the consistency and defensibility of documentation and evidence through product launch and lifecycle updates.
FAQs
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Regi is a workflow-based regulatory execution platform for teams building Software as a Medical Device (SaMD) and AI-enabled medical devices. It turns complex regulatory expectations into step-by-step, review-ready workflows across the product lifecycle.
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Regi is designed to produce regulator-ready outputs aligned to UKCA, EU MDR, and FDA expectations, helping teams structure evidence and documentation for those pathways.
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Regi breaks regulatory tasks into structured flows that prompt for required inputs, explain why each input matters, and map everything into coherent outputs. This reduces late-stage surprises by checking completeness and consistency as you work.
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Regi supports execution across pre-market and post-market, starting with early regulatory framing, through preparation/maintenance of core regulatory documentation, and into structured post-market handling and periodic reporting.
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Regi provides structured workflows for PMS planning and reporting, plus consistent event intake and triage (severity, reportability, rationale, timelines) that can be reused in periodic reports. This is designed to improve discipline, traceability, and reduce rework.
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Yes. AI is used as decision support to flag gaps, contradictions, or weak justification, and to explain what needs attention and why. It can suggest draft text based strictly on user-provided information, but outputs remain under human control.
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Regi is built around a strict human-in-the-loop model with clear review/sign-off points, version control, and audit trails linking inputs, assumptions, and outputs. AI suggestions are labelled and do not replace professional judgement or make regulatory decisions autonomously.
