Regi's intelligent workflows help early-stage SaMD and AI device teams navigate the regulatory process and avoid the common mistakes that compound later.
No regulatory department needed.
Avoid regulatory debt before it compounds.
Explainable, review-ready artefacts from day one.
Cost overrun from late-stage regulatory rework
Timeline slip for first regulated releases
Cost of market entry errors caught late
* Sources: BrightInsight/HealthXL SaMD Executive Survey; Medical Consulting Group UK SaMD Cost Guide 2025
Finding the requirements is the easy part. Building a plan and managing the compliance process is challenging, especially on a shoestring or without a big team.
Decisions get made in different documents with different rationale, while risks, claims, evidence, and PMS linkages get patched in late. These compound over time, leading to intended purpose errors, misclassification, consultant costs, delays, rework, and submission timeline slip.
AI Assist flags hazards you haven't considered, explains gaps in your inputs, and grounds its suggestions in the relevant guidelines. You get expert-level challenge without hiring an expert.
Regi walks you through the early decisions that shape everything downstream: intended purpose, claims boundaries, classification and evidence. Guidance Panels explain what is required and why at every step, in plain language designed for teams at any experience level, with workflows aligned to UKCA, EU MDR/IVDR and FDA.
Document Wizards guide you step by step through creating PMS plans, clinical evaluation reports, and risk management files. No more "we know the rules, now what?" Regi turns regulatory expectations into finished, defensible artefacts.
Capture the why behind every decision as you work, so you're not reverse-engineering your story for a regulator later. No gaps, no guesswork, no consultant call to explain what you did.
Regi doesn't replace your QMS/RIM. It makes it easier to produce coherent, review-ready outputs for advisors and notified bodies without building a full regulatory team.
Everything you need to approach your first regulated release with confidence.
Create a dedicated workspace and pick your market. Everything stays isolated and organised from day one.
Guided wizards walk you through each step. AI flags hazards and gaps; plain-language panels explain why each input matters.
Inputs captured once flow automatically across risk, evidence, and PMS. No spreadsheets, no reconciliation.
Traceability links build automatically as docs evolve. PMS monitoring starts as soon as your plan is in place.
AI triages adverse events and flags signals. No dedicated surveillance resource needed.
Review and approve every AI suggestion. Nothing counts until you sign it off.
Try Regi free and see how it handles your device, your market, and your regulatory questions.