RuleMedi
Compass
Six Pillars. One Evidence Spine. Continuous Inspection Readiness.
Compass is the clarity and execution engine of RuleMedi. It transforms the dense language of EU MDR, IVDR, and UKCA into structured, evidenced, and inspection-ready outputs across six fully integrated compliance pillars — so that every regulatory obligation becomes a demonstrable, auditable asset. In a regulated environment, credibility depends on demonstrable control. Compass delivers it.
The Six Pillars of Continuous Compliance
Compass delivers comprehensive regulatory control through six fully integrated pillars. These capabilities are built into the platform by default — no add-ons, no modules to purchase separately — providing a complete, 360-degree view of your compliance posture from day one.
Compliance
FROM OBLIGATION TO EVIDENCE – AUTOMATICALLY.
Compass decomposes EU MDR, IVDR, and UKCA requirements into a structured obligation library, maps each requirement to your GSPR and Technical Documentation, and monitors regulatory change with automatic impact routing. Your team always knows what is required, what is evidenced, and what is outstanding.
Risk
CLOSED-LOOP RISK GOVERNANCE ACROSS THE DEVICE LIFECYCLE.
Govern device, clinical, manufacturing, and post-market risks with full governance-grade accountability. Risk controls link directly to GSPR obligations and Technical Documentation, creating a closed loop that responds to real-world signals from your PMS programme — not just a static risk register.
Training
COMPETENCE YOU CAN PROVE, NOT JUST CLAIM.
Deliver role-based training with traceable learning paths and audit-ready evidence. Every function — RA/QA, Clinical, Manufacturing, Vigilance — can demonstrate it is trained and current on regulatory duties and internal procedures. When a Notified Body asks for training records, Compass produces them instantly.
ESG
SUSTAINABILITY CLAIMS THAT STAND UP TO SCRUTINY.
Produce evidence-backed ESG and ethical governance outputs using the same discipline as your regulatory compliance programme. Map ESG controls to internal policies, supplier governance, and reporting artefacts — so your sustainability position is as defensible as your CE marking.
Executive Governance
BOARD-LEVEL CLARITY ON COMPLIANCE POSTURE.
Give leadership a single, explainable view of compliance status, risk exposure, and inspection readiness — without requiring them to interpret raw regulatory data. Dashboards highlight what is changing, what is overdue, and what requires immediate attention, with named accountable owners and deadlines.
Regulatory Inspection
CONTINUOUS NOTIFIED BODY READINESS – NOT A SPRINT BEFORE AUDIT.
Achieve a permanent state of inspection readiness. Compass prepares NB-ready evidence packs, runs structured mock audits, manages gap-closure programmes, and ensures all evidence is complete, consistent, and instantly retrievable — for any surveillance visit, renewal, or MHRA inspection.
One Operating Model. Two Distinct Markets.
The EU and UK medical device regulatory regimes are now substantively different — and diverging further. Compass maintains a single evidence spine and a single governance layer, while automatically outputting the correct jurisdiction-specific artefacts for each market. You do not build two compliance programmes. You build one, and Compass handles the rest.
Northern Ireland sits within the EU regulatory framework for medical devices. Compass manages this distinction automatically, ensuring your NI-placed devices meet EU MDR/IVDR requirements without requiring a separate evidence management system.
🇪🇺 European Union & Northern Ireland
Full alignment with EU MDR (2017/745) and IVDR (2017/746)
CE marking and Notified Body readiness — surveillance and renewal cycles
EUDAMED registration and UDI workflows
Northern Ireland Protocol — EU rules apply, managed within the same evidence spine
MDCG guidance integration and SCENIHR opinion monitoring
🇬🇧 Great Britain (England, Scotland, Wales)
Full alignment with UK MDR 2002 (as amended) and UKCA marking
MHRA registration and PRRC accountability requirements
Readiness for the strengthened UK PMS regime (SI 2024/1368)
Separate GB market evidence management — distinct from EU artefacts
Automatic divergence monitoring as UK and EU regulations evolve independently
Our Training & Support Promise
We are committed to your success from day one. We are not just a vendor — we are your partner in compliance.
Structured Onboarding
Every Compass deployment includes a structured onboarding programme at no additional cost. Your RA, QA, and Clinical teams will be trained, configured, and confident before go-live — not learning on the job.
Embedded Regulatory Education
Regulatory education is built into the platform itself. As regulations evolve — new MDCG guidance, MHRA updates, implementing acts — Compass surfaces the changes and explains their implications in plain language.
Inspection Cycle Support
We align our support to your audit and certification cycles. Whether you are preparing for a Notified Body surveillance visit, an MHRA inspection, or an internal audit, we ensure you are ready — not scrambling.
Ready for Inspection-Ready Compliance?
Book a personalized Compass demonstration and see how we can transform your regulatory posture.