Post Market Surveillance,
built for how
it actually works.
One platform for Complaints, CAPA, Field Actions and Recalls – engineered around real workflows, optimised for every click, and ready to produce audit-grade documentation the moment it is needed.
The Problem We Solve
PMS is too important to run on spreadsheets and generic tools
Most companies manage their post market surveillance in systems that were never designed for it. Complaints live in email threads. CAPAs are tracked in Excel. Recalls are assembled under pressure, from scratch, every time.
The result is avoidable risk, wasted hours, and documentation that does not hold up in an audit. We built a tool that eliminates all of that – module by module, click by click.
Workflow-native design
Every screen, every field and every transition mirrors the actual regulatory process – not a generic form adapted after the fact.
AI-assisted standard phrases
Phrase libraries drawn from historical data, industry best practice and years of regulatory experience – or generated by AI on demand.
Audit-ready output, always
Every module can export a clean, authority-facing document that shows exactly what needs to be shown – and nothing that should stay internal.
Focus on content, not process
Teams spend their time on the substance of quality decisions, not on navigating the tool or formatting the output.
The Platform
Four core modules. One connected workflow.
Each module is purpose-built for its domain and deeply connected to the others. A complaint can become a CAPA. A CAPA can trigger a Field Action. Every step is traceable, documented and audit-ready.
Complaints
Capture, triage and close complaints from any source – call centres, field reports, service returns – in a single, structured workflow that meets MDR, FDA 21 CFR Part 803 and equivalent requirements.
- Structured intake with AI-assisted categorisation
- Regulatory reportability assessment built in
- Automatic linkage to affected lots, products and markets
- Standard phrase libraries for root cause and justification text
- Export to authority-facing MDR / MDV format
More detail coming soon
01
CAPA
Manage corrective and preventive actions end-to-end – from problem identification through root cause analysis to effectiveness verification – with full traceability to source events.
- Structured root cause analysis with guided methodologies
- Action planning with owner assignment and deadlines
- Effectiveness check workflows with criteria templates
- Cross-links to complaints, field actions and change requests
- Audit-clean summary export at any stage
More detail coming soon
02
Field Actions
Plan, execute and document field safety corrective actions and advisory notices with the speed and precision that regulators and customers expect – without building everything from scratch each time.
- Pre-structured FSN and FSCA templates by jurisdiction
- Distribution list and customer notification tracking
- Response rate monitoring and escalation workflows
- Regulator submission documentation auto-assembled
- Clean separation of internal planning and external output
More detail coming soon
03
Recalls
Execute recalls with confidence. From initial scope definition to final effectiveness check, every required element is guided, tracked and documented so that nothing falls through the cracks under pressure.
- Lot and distribution tracing with scope calculator
- Health hazard evaluation documentation support
- Regulatory agency notification packages (FDA, BfArM, TGA…)
- Customer contact and return tracking dashboards
- Effectiveness check criteria and closure documentation
More detail coming soon
04
Change Requests & Periodic Reports – automatically derived
Because the data already lives in the platform, change requests and periodic safety reports no longer have to be assembled manually. The tool draws on the complete activity history to generate structured drafts that are accurate, traceable and ready to review.
Change Requests
- Generated from CAPA and Field Action outcomes
- Linked to original risk assessment and design documentation
- Pre-formatted for design change control workflows
More detail coming soon
Periodic Reports (PSUR / PMSR)
- Auto-populated from complaint, CAPA and field action data
- Structured to MDR Annex III / IVDR requirements
- Configurable reporting periods and product scope
More detail coming soon
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Platform Design
Three principles behind every module
Optimised for every click
The tool was designed by people who have done this work themselves. Every screen removes friction. Default values are intelligent. Standard phrases mean the user is writing less and thinking more.
Built-in regulatory intelligence
Requirements from MDR, FDA, TGA and other major jurisdictions are embedded in the workflow logic – not in a manual you have to consult separately. The tool guides, reminds and validates as you work.
Separation of internal and external
Every artefact has two layers: the working document with full context, and the clean export for regulators and notified bodies. One click, no editing, no risk of sharing the wrong version.
Get Started
See the tool in the context of your own processes
We walk you through the platform using your workflows, your products and your regulatory context. No generic demo.