RapidFacto

Design controls

User needs, design inputs and outputs, verification, validation, risk, traceability, and DHF.

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

Infusion Pump v3

18 requirements
RequirementsTestsRisksTraceabilityDocumentsReviews
IDRequirementComponentCategoryStatus
DI-1Display must provide real-time flow feedbackUIUsabilityApproved
DI-2Housing withstands 1.2 m drop without fluid leakEnclosureSafetyIn review
DI-3Occlusion alarm within 15 seconds at 10 psiSensorsPerformanceChanged
DI-4Battery runtime ≥ 8 hours at max ratePowerPerformanceNew

Manufacturers using RapidFacto

Trusted by 30+ medical device manufacturers

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

Most plants still keep design in Word and risk in Excel. RapidFacto puts user needs, inputs, outputs, tests, and risk on the product — then transfers approved design into BMR and QC with the same history.

Why design controls stall on the shop floor

R&D writes requirements in Word. Quality tracks risk in Excel. Manufacturing only sees the DHF when an auditor asks for it. When a design input changes, it is not obvious which tests, risks, or batch records are now out of date.

  • Open the DHF from the product record instead of assembling it the week before inspection
  • Catch missing links, open risks, and stale tests before an auditor does
  • Move approved design into manufacturing without losing the requirement trail
app.rapidfacto.com / design-controls / infusion-pump-v3

Infusion Pump v3

18 requirements
RequirementsTestsRisksTraceabilityDocumentsReviews
IDRequirementComponentCategoryStatus
DI-1Display must provide real-time flow feedbackUIUsabilityApproved
DI-2Housing withstands 1.2 m drop without fluid leakEnclosureSafetyIn review
DI-3Occlusion alarm within 15 seconds at 10 psiSensorsPerformanceChanged
DI-4Battery runtime ≥ 8 hours at max ratePowerPerformanceNew

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

18 requirements
RequirementsTestsRisksTraceabilityDocumentsReviews
IDRequirementComponentCategoryStatus
DI-1Display must provide real-time flow feedbackUIUsabilityApproved
DI-2Housing withstands 1.2 m drop without fluid leakEnclosureSafetyIn review
DI-3Occlusion alarm within 15 seconds at 10 psiSensorsPerformanceChanged
DI-4Battery runtime ≥ 8 hours at max ratePowerPerformanceNew

Requirements

Requirements on the product, not in a shared drive

Capture user needs and design inputs by product, component, and category. Status, owner, and revision sit on the same record quality and engineering both use.

  • Requirements table with ID, component, category, and status
  • Attachments and design outputs linked to the input they cover
  • Same product record as QMS documents, manufacturing, and QC
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
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 / dhf

Design History File

Ready to export

Design & development plan

Rev 4

Approved

User needs & design inputs

Rev 6

Approved

Risk management file

Rev 3

In review

V&V protocol & reports

Rev 2

Changed

Design review minutes

DR-3

Approved
Download DHF pack

DHF

Design History File from live records

The DHF is the approved plan, inputs, risk file, V&V, and review minutes — not a zip file assembled the night before CDSCO arrives.

  • Index built from approved design records
  • Design reviews with attendees, decisions, and Part 11 e-signatures
  • Export a DHF pack for ISO 13485 and CDSCO inspections
app.rapidfacto.com / design-controls / transfer

Design transfer

Linked to BMR
DO-12 Housing specBMR step · Injection mould
DI-3 Occlusion alarmIPQC · Alarm response
VAL-4 Bench protocolFG test · Occlusion check

Design transfer

Transfer approved design into manufacturing

Approved outputs become the specs BMR, IPQC, and FG tests run against. A complaint or recall can still reach the original requirement.

  • Map design outputs to BMR steps and QC specifications
  • Keep the design-to-batch link after transfer
  • A revised input flags the manufacturing and QC records it touches

Explore other modules

Design controlsDocumentsChange controlCAPATrainingAuditsRisksSuppliersComplaints & PMSQMSManufacturingQuality controlPurchaseStores & inventoryApprovalsReports & compliance

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.

Reports & compliance

20+ automated PDF reports — BMR, COA, inspection reports, purchase orders — with full audit trail for medical device manufacturers.