Regi's intelligent workflows help established SaMD and AI device teams manage change, scale compliance across a portfolio, and stay audit-ready across UKCA, EU MDR and FDA.
Across products, markets, and teams.
Without rewrites or fire drills.
AI-powered adverse event triage and trend analysis keep you audit-ready.
The challenge isn't knowing the rules. It's keeping everything aligned and current.
Once you have multiple products, multiple markets, and multiple teams, definitions drift between documents, evidence lives in different places, and changes in product, data sources, or AI behaviour ripple into claims, risk controls, labelling, PMS and reporting.
That's when organisations get hit by avoidable rework: inconsistent intended purpose wording across markets, duplicated evidence efforts, patchwork PMS activities, audit fire drills, and slowdowns when expanding indications or launching new versions.
AI Assist works the same way for every team member across every product — same hazard suggestions, same gap checks, same guideline grounding — so audit posture doesn't depend on who ran the workflow.
Each product lives in its own device-specific workspace with isolated data. The Traceability Hub and Essential Requirements Matrix (GSPR) link hazards to controls and verification consistently across every product, so each team builds on the same foundation rather than reinventing it.
When the product evolves, Document Wizards guide you through updating the affected sections of PMS plans, clinical evaluation reports, and risk management files. Regi keeps your narrative coherent across submissions, PMS and technical documentation without a manual audit of every linked artefact.
Capture decision logic as you go, maintain version history, and produce structured outputs that stand up to internal review, notified bodies and auditors.
Regi doesn't replace your QMS/RIM. It's the execution layer that keeps your regulatory work connected, consistent, and easier to run at scale.
The building blocks for consistent, scalable regulatory execution across your entire portfolio.
All products on one dashboard. Each sits in its own isolated workspace — data never leaks between products or markets.
Guided wizards keep every team consistent across PMS plans, clinical evaluations, and risk files, regardless of individual experience.
Product-specific context flows automatically across risk, evidence, traceability, and PMS per device.
Traceability and requirements links update automatically as each product evolves. PMS monitoring runs in the background portfolio-wide.
AI triages adverse events per device and monitors signals across the portfolio, surfacing issues before they compound.
Review and approve every AI suggestion — across every team member and every product in the portfolio.
See how Regi handles your portfolio structure — book a demo with your products in mind.