RuleMedi
Compass
Inspection-Ready Clarity. Goverened Execution
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, ensuring every obligation becomes a demonstrable, auditable asset. In regulated healthcare, 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
Automate MDR/IVDR obligation tracking, decompose requirements, and map evidence to GSPR. Outputs include an obligation library mapped to internal procedures, GSPR coverage views, Technical Documentation assembly cues, and change monitoring with impact routing.
Risk
Govern device, clinical, manufacturing, and post-market risks with governance-grade accountability. Link risk controls directly to GSPR and Technical Documentation to build a resilient, closed-loop risk system that responds to real-world signals from your PMS programme.
Training
Deliver role-based competence with traceable learning paths and audit-ready training evidence. Ensure every function — from RA/QA and Clinical to Manufacturing and Vigilance — can demonstrate it is trained and current on regulatory duties and internal processes.
ESG
Produce evidence-backed sustainability and ethical governance claims that stand up to scrutiny. Map ESG controls to internal policies, supplier governance, and reporting artefacts, using the same evidence discipline as your regulatory compliance programme.
Executive Governance
Provide leadership with a single, explainable view of compliance status, risk posture, and inspection readiness. Board-level dashboards highlight what is changing, what is overdue, and what requires immediate attention — with clear accountable owners and deadlines.
Regulatory Inspection
Achieve a state of continuous Notified Body readiness. Prepare NB-ready evidence packs, run mock audits, manage gap-closure programmes, and ensure all evidence is complete, consistent, and instantly retrievable for any assessment or surveillance visit.
One Operating Model. Multiple Jurisdictions.
Compass operates seamlessly across the complex and distinct regulatory environments of the European Union and the United Kingdom. Rather than building separate systems, Compass maintains a single evidence spine, a single governance layer, and a single post-market engine, while automatically outputting the correct jurisdiction-specific artefacts for each market.
🇪🇺 European Union & Northern Ireland
Full alignment with EU MDR (2017/745) and IVDR (2017/746)
CE marking and Notified Body readiness
EUDAMED registration workflows
Northern Ireland Protocol (EU rules apply)
🇬🇧 Great Britain (England, Scotland, Wales)
Full alignment with UK MDR 2002 (as amended)
UKCA marking and MHRA registration
Readiness for strengthened PMS regime (SI 2024/1368)
Separate GB market evidence management
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.
Free Onboarding Training
Every Compass deployment includes initial onboarding training at no additional cost, ensuring your team is confident and productive from day one.
Embedded Regulatory Education
Ongoing regulatory education is embedded within the platform itself, keeping your team current as regulations evolve.
Continuous Audit Support
Continuous support aligned to your audit and certification cycles, ensuring you are always prepared for the next assessment.
Ready for Inspection-Ready Compliance?
Book a personalized Compass demonstration and see how we can transform your regulatory posture.