Medical device manufacturing
Validated evidence, assembled continuously
In a regulated device operation the quality system is the product record. The platform keeps inspection results, electronic signatures, deviations and corrective actions bound to the device and its design history, so audit readiness is a state you are in rather than a project you run.
- record traceability
- 100%
- audit preparation
- -3 days
- evidence retrieval
- < 1 min
- open findings at last audit
- 0
Standards supported
- ISO 13485
- FDA 21 CFR Part 11
- EU MDR
- ISO 14971
Typical monitored characteristics
- Dimensional CTQs
- Seal integrity
- Sterility indicators
- Bioburden
- Torque
- Functional test
Where the cost sits
The problems we start from
These are the recurring findings from discovery workshops in this sector. If none of them describe your operation, a pilot is probably premature — and we will say so.
Operational problems
Audit evidence is assembled by hand
Each inspection, notified body or customer audit triggers a document-gathering exercise across paper batch records and several systems.
Deviations move slowly
Paper-based deviation and CAPA routing means approvals wait for people to be physically available, extending time to disposition.
Design history is disconnected from production
The link between a design requirement, its verification and the production evidence is maintained manually and drifts over time.
Validation effort discourages tooling change
Fear of revalidation keeps teams on spreadsheets, which are themselves difficult to defend during audit.
Engineering constraints
Computer system validation
Any system touching quality records requires validation, so change management and documentation must be built in, not added later.
Electronic signature integrity
Part 11 requires signature binding, non-repudiation and complete audit trails with no destructive edits.
Multi-jurisdiction requirements
FDA, EU MDR and national requirements overlap but differ in evidence expectations and retention periods.
Small batch, high documentation ratio
Documentation effort per unit is high, so automation of evidence has a disproportionate effect on cost.
Platform capabilities
How the platform is configured for medical devices
Same architecture, same modules — configured against the characteristics, sampling logic and evidence expectations of this sector.
Part 11 electronic records
Signature binding, immutable audit trail, retention policy enforcement and controlled document revisions as standard behaviour.
Deviation and CAPA workflow
Routing with role-based approval, effectiveness verification and full history, replacing paper handoffs between shifts.
Design history linkage
Ties production evidence to the design requirement and verification it satisfies, so DHF review stops being archaeology.
Validation package
IQ/OQ documentation, traceability matrix and change-control artefacts provided as part of an enterprise agreement.
Process capability evidence
Continuous Cp/Cpk evidence on critical characteristics rather than a capability study performed once at qualification.
- SAP
- Veeva-style DMS via API
- Mitutoyo
- OPC UA
- Microsoft Entra ID
- ServiceNow
Business outcomes
What changed for operations like yours
Customer-reported figures measured against documented pre-deployment baselines. Ranges, not single numbers, because process maturity dominates the result.
- Traceable records
- 100%
- Audit preparation
- -3 days
- Deviation cycle time
- -52%
- Evidence retrieval
- < 1 min
Traceable records
Within configured scope
Audit preparation
Per notified body or customer audit
Deviation cycle time
Electronic routing replaces paper
Evidence retrieval
Was up to three days
| KPI | Typical movement | Measurement note |
|---|---|---|
| Audit preparation effort | -60% to -80% | Evidence generated from live records |
| Deviation cycle time | -40% to -55% | Electronic routing and approval |
| CAPA effectiveness verification | 96% verified | Measured post-implementation |
| Record completeness | 100% | Mandatory fields enforced at capture |
| Right-first-time documentation | +25 pt | Fewer documentation deviations |
Expected ROI
A value case your controller can interrogate
Every line below is an assumption, not a promise. During a pilot each one is replaced with a measured figure from your own baseline, which is what makes the business case defensible in a capital review.
| Value driver | Assumption | Annual |
|---|---|---|
| Audit and documentation effort | 70% of preparation effort removed | €190k |
| Deviation cycle time | Faster disposition releases held stock sooner | €240k |
| Scrap and rework | Earlier detection on monitored characteristics | €160k |
| Avoided finding remediation | One major finding avoided every two years | €120k |
| Indicative total | Before platform and integration cost | €710k |
Payback
7–12 months
From first connector to cumulative break-even
How we validate it
- Baseline recorded before any change
- Success criteria written into the pilot scope
- Measured comparison in the pilot report
- Exit conditions agreed up front
Illustrative model. Compliance outcomes depend on your configured, validated process; the platform supplies the evidence.
Electronic signatures and an immutable audit trail replaced manual assembly of inspection evidence, cutting audit preparation from days to hours with no findings at the last inspection.
Related sectors: Automotive, Battery manufacturing, Semiconductor
Start the evaluation
Find out where quality drift is hiding in your plant.
Bring one line, one defect family or one audit workflow. We will map the available data sources, quantify the cost of the current detection delay, and show the fastest route to measurable control.
45-minute technical walkthrough
With a solution architect who knows manufacturing data, not a scripted demo.
NDA before any data review
We can assess feasibility from sample exports without production access.
Written pilot scope
Baseline metrics, success criteria and exit conditions agreed up front.