Assess, validate, remediate, submit, maintain
One model across every service and market. AI speeds up the first pass; specialists decide what goes into your file.
- 01
Assess
AI-assisted initial assessment of your file, QMS or portfolio against the applicable requirements.
GapSmart AI - 02
Validate
Expert delta review. Specialists confirm, correct and prioritise every finding.
Specialist review - 03
Remediate
Controlled documentation, authored and updated under document control with evidence references.
WriteCortex AI - 04
Submit
Regulatory support: dossier compilation, submission and review-cycle management.
Regulatory team - 05
Maintain
Lifecycle compliance: PMS, vigilance, changes and renewals.
IntelliVigilance AI
AI involvement varies by project scope, tool readiness and the level of human review required.
A structure built for review
Every engagement has a single accountable contact, practice leads for each workstream, and independent review before anything reaches you.
Priorities, approvals, escalation
Strategic partnership and oversight
Client relationship, communication and delivery tracking
Senior regulatory analysts
Senior medical writers
PMS and complaint specialists
Scientific and clinical sign-off
Consistency, accuracy and QMS compliance
| Forum | Cadence | Output |
|---|---|---|
| Work-stream stand-up | Daily, 15 min | Task board and same-day actions |
| Status review | Weekly, 30 min | KPI snapshot, risk log, resourcing |
| Steering committee | Quarterly, 60–90 min | Roadmap, change requests, minutes |
| Service level | Target |
|---|---|
| First-time-right drafts | ≥ 95% |
| Final documents free of critical errors | ≥ 99.5% |
| On-time completion against plan | 100% |
| Routine query response | ≤ 24 business hours |
| Urgent query response | ≤ 4 business hours |
Service-level figures are targets, not historical results. Definitions, measurement and exclusions are agreed in each statement of work.
Every deliverable passes the same gates
Our ISO 13485-certified QMS governs how documents are written, reviewed and released to you.
- 01AuthorSpecialist drafts against the agreed template and evidence.
- 02SME reviewTechnical and regulatory accuracy checked by a senior specialist.
- 03Medical reviewClinical content reviewed by a medically qualified specialist where applicable.
- 04QC checkConsistency, references and formatting verified.
- 05Client review and releaseYour comments resolved; document released into your system.
Ways to work with us
| Engagement model | Best fit | Typical scope |
|---|---|---|
| Dedicated regulatory team | Ongoing documentation and QMS support | Named specialists working as an extension of your team |
| Fixed-scope project | A CER, PER, technical file or regulatory submission | Defined deliverables, milestones and acceptance criteria |
| Interim and specialist support | Short-term expertise or interim cover for a role | Reviews, audits, workshops or an interim RA, QA or PMS lead |
| Managed compliance service | Sustained QMS, PMS and vigilance operations | Outsourced or co-sourced operations with service levels |
| AI pilot or proof of concept | Evaluating MedoQi technology on a controlled use case | A time-boxed pilot with agreed success measures |
Commercial options include dedicated FTE billing, time and material, milestone-based fixed fees and unitised fees per deliverable, delivered onshore, offshore or hybrid. Details are set out in each proposal.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.