Compliance intelligence for regulated digital health.
Vera is MediLife's proprietary compliance intelligence platform. It strengthens our engineering and regulatory reviews by analysing your development documentation against recognised medical device standards before formal review begins — so issues surface early, when they are still cheap to fix.
See where you're ready — and where you're exposed.
Vera maps the evidence you already have against the requirements that apply, showing coverage, gaps and regulatory risk in one structured assessment.
| Area | Major | Minor | Priority |
|---|---|---|---|
| QMS | 11 | 16 | High |
| Risk Management | 7 | 9 | High |
| Software Lifecycle | 5 | 11 | Medium |
| Verification | 4 | 6 | Medium |
| Standard / Clause | Requirement | Evidence & Finding | Risk | Recommended Action |
|---|---|---|---|---|
| ISO 13485 §4.1 | General requirements | No formally documented, implemented QMS evidence found for this clause | High | Establish and document QMS procedure covering §4.1 scope |
| ISO 14971 §7.1 | Risk control verification | Risk controls implemented but no verification records located | High | Generate verification evidence for each implemented risk control |
| ISO 13485 §7.3.6 | Design verification | Verification plan exists; sign-off records incomplete | Medium | Complete and file verification sign-off records |
Illustrative example — figures shown are sample data, not client results.
Three levels, one assessment.
Where are we?
Overall readiness, evidence coverage, major gaps and priority areas.
Why?
Standards, clauses, evidence and requirement-level findings.
What do we do next?
Prioritised remediation actions.
Five stages, start to finish.
- 01
Client Documentation
You provide the existing documentation set — procedures, design records, risk files, verification evidence.
- 02
Vera Analysis
Vera maps the evidence against applicable clauses using fixed, rule-based logic.
- 03
Engineering & Regulatory Review
A MediLife specialist reviews the analysis and applies judgement to context and materiality.
- 04
Client Report
You receive findings linked to applicable requirements, prioritised by risk.
- 05
Remediation Plan
A practical, prioritised plan for closing the gaps that matter most.
This is not a fully automated pipeline. Human experts remain responsible for judgement and recommendations at every stage.
Across the full evidence set.
Software Development Documentation
Plans, procedures and lifecycle records.
Requirements & Traceability
Links from requirement to design, test and risk.
Software Architecture
Structure, interfaces and SOUP handling.
Risk Management
Hazard analysis, controls and control verification.
Verification & Validation
Test coverage, records and sign-off evidence.
Technical Documentation
Submission-facing files and supporting evidence.
Quality Management System Documentation
Procedures, records and process coverage.
AI & Machine Learning Evidence
Where applicable — data, performance and change control records.
- IEC 62304
- ISO 13485
- ISO 14971
Three deliverables, one review.
Every Vera-supported review produces three things — not a technology subscription, but a defensible position for your specific product.
Executive Readiness Summary
Overall position, priority risks and areas requiring attention.
Detailed Veracity Report
Requirement-level findings, evidence gaps, inconsistencies and risk.
Prioritised Remediation Plan
What needs fixing, why it matters and what should happen first.
Recommended SOP update: add a unit-level verification checklist referencing §5.5.3 prior to integration testing. Require signed evidence per software unit and link records to the design history file.
Recommended action: introduce a risk-control verification record for each mitigation identified in the risk management file, cross-referenced to the corresponding verification test result.
Technology where it helps. Expertise where it matters.
Vera
Maps, checks, cross-references and identifies.
MDH Specialists
Review, interpret, challenge and prioritise.
Client
Receives a defensible assessment and actionable remediation plan.
Amplified expertise, not automated judgement.
Nothing here is a regulatory determination made by software. Every finding is interpreted and validated by a specialist before it reaches you.
Ready to see what Vera finds?
Whether you're preparing for regulatory submission, reviewing an existing development programme or assessing technical documentation, Vera can help identify issues before they become costly delays.