RapidFacto

Risk management

Score hazards next to the requirement. Link mitigations to outputs and tests.

View pricing
app.rapidfacto.com / design-controls / infusion-pump-v3

Infusion Pump v3

ISO 14971
RequirementsTestsRisksTraceabilityDocumentsReviews

Severity × occurrence

1
2
3
4
5
5
4
R-04
3
2
1

R-04 · Occlusion undetected

Mitigation: DI-3 alarm spec + VAL-4 bench test

Residual risk: ALARP · pending review

Manufacturers using RapidFacto

Trusted by 30+ medical device manufacturers

  • J Mitra & Bros
  • Dentmark
  • Adlisc
  • Aminov Medical Devices
  • Sigma International

A risk file in Excel is already stale when design changes. RapidFacto keeps severity, occurrence, and mitigations on the product, next to the design input they belong to.

Risk sits on the product, not in a workbook

  • Risk is not a workbook someone emailed last quarter
  • A design change shows which risks need another look
  • Residual risk is explicit before you transfer to manufacturing
app.rapidfacto.com / design-controls / infusion-pump-v3

Infusion Pump v3

ISO 14971
RequirementsTestsRisksTraceabilityDocumentsReviews

Severity × occurrence

1
2
3
4
5
5
4
R-04
3
2
1

R-04 · Occlusion undetected

Mitigation: DI-3 alarm spec + VAL-4 bench test

Residual risk: ALARP · pending review

Capabilities

What your team uses in RapidFacto

Illustrated from the live product — each module below stands on its own.

app.rapidfacto.com / design-controls / infusion-pump-v3

Infusion Pump v3

ISO 14971
RequirementsTestsRisksTraceabilityDocumentsReviews

Severity × occurrence

1
2
3
4
5
5
4
R-04
3
2
1

R-04 · Occlusion undetected

Mitigation: DI-3 alarm spec + VAL-4 bench test

Residual risk: ALARP · pending review

ISO 14971

Risk on the same record as the requirement

Score hazards next to the design input. Link mitigations to outputs and tests, and keep residual risk visible until it is accepted.

  • Severity, occurrence, and detectability per product
  • Mitigations linked to design outputs and verification
  • Open risks stay on the dashboard until closed or accepted
app.rapidfacto.com / design-controls / infusion-pump-v3

Infusion Pump v3

Live matrix
RequirementsTestsRisksTraceabilityDocumentsReviews

User need → input → output → validation

Download matrix

User need

UN-1Approved

Easy-to-read display at the bedside

Design input

DI-1Approved

Display must provide real-time flow feedback

DI-5Changed

Contrast ratio ≥ 4.5:1 in 500 lux

Design output

DO-1Approved

TFT UI spec · Rev 3

Validation

VAL-2Changed

Usability study · 15 nurses

Traceability

Traceability matrix from user need to V&V

See user need → design input → output → validation in one view. Prompt the team when a link, risk, or test is missing.

  • Flags for missing connections, unresolved risks, and outdated tests
  • Changing a requirement shows which V&V evidence is affected
  • Download the matrix for the DHF or an inspector

Explore other modules

Design controlsDocumentsChange controlCAPATrainingAuditsRisksSuppliersComplaints & PMSQMSManufacturingQuality controlPurchaseStores & inventoryApprovalsReports & compliance

Design controls

User needs, design inputs and outputs, verification, validation, risk, traceability, and DHF for medical device manufacturers — ISO 13485 and CDSCO audit-ready.

QMS

ISO 13485 QMS software — document control, CAPA, training, internal audit, logbooks, complaints, and management review for medical device manufacturers.

Manufacturing

Digital batch manufacturing records, IPQC, finished good testing, and batch release for medical device manufacturers — ISO 13485 and CDSCO audit-ready.