Inputs → Reasoning → Outputs

Regulatory parameters (various regs)

Explainability / traceability

Example workflow (use case)

CTA

H1: The evidence intelligence layer for AI SaMD

Subhead: Regi turns live product context — intended use, claims, risk profile, change history and markets — into a continuously updated evidence plan aligned to MDR and SaMD guidance. 

CTA: Request a demo

Overview: what Regi does

H2: What Regi does

Regi converts product, market and risk context into:

  • Pre-market evidence requirements (what you must prove, by framework)

  • A defensible rationale (why this evidence is required)

  • Post-market obligations (what must be monitored and updated after launch)

Core modules

H2: Core modules

1) Evidence Planning (MDR / SaMD)

Create a cross-framework evidence plan that links intended use → claims → risk → evidence requirements.

2) Post-Market Surveillance (PMS)

Build PMS plans that stay connected to pre-market assumptions and evolve with real-world data.

3) Outputs & Exports

Generate structured, regulator-ready outputs designed to feed QMS and RIM systems (DOCX/PDF/structured exports where applicable). 

“Not a QMS or RIM”

H3: Regi is not a QMS or a RIM system

Regi sits upstream and alongside your existing regulatory infrastructure, strengthening it with consistent, explainable evidence intelligence — not replacing core QMS/RIM workflows.

Feature comparison (category-level)

Use your existing category table here, framed as:

H2: Category comparison (typical strengths by category)

/how-regi-works

H1: Inputs → reasoning → outputs

Subhead: Regi turns live product context into regulator-ready evidence plans and PMS documentation, with explicit rationale. 

The 3 steps

Step 1: Inputs (product reality)

Intended use, clinical claims, classification context, risk baseline, AI/ML change context, target markets.

Step 2: Reasoning (evidence intelligence)

Map requirements across frameworks, justify evidence and rationale, maintain traceability as product changes.

Step 3: Outputs (regulator-ready)

Evidence plans, PMS plans/updates, structured rationale, exportable documentation designed for QMS/RIM integration.

Example workflow (use-case block

Pick one concrete storyline (simple, non-technical):

Example: “New AI SaMD preparing EU MDR + UKCA launch”

  • Define intended use + claims

  • Generate evidence requirements with rationale

  • Produce PMS plan aligned to assumptions

  • Export outputs for QMS/RIM use