Your Device History Record should be complete when production ends — not assembled days later
Connect production equipment, test stations, ERP, and quality systems in one place. FlowFuse helps teams capture process data in real time, automate DHR assembly, enforce change control, and maintain complete component traceability across products and sites.
The Problem Today
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Device History Records are assembled manually at end of production by pulling data from multiple disconnected systems — delaying product release and introducing transcription errors into regulatory records that FDA 483s consistently flag.
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Non-conformances are reported ad hoc, with CAPA initiated as a separate manual step — disconnected from the production data that caused the event and difficult to defend in FDA or Notified Body audits.
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Engineering Change Orders are communicated by email; some lines run on outdated revision levels, creating non-conformance risk and potential recall exposure.
What You Get with FlowFuse
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One platform to connect production and test data (assembly stations, test fixtures, process equipment) with quality and ERP systems (MES, CMMS, QMS).
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Low-code automation built on Node-RED so engineers can configure and deploy workflows within a validated framework — without rebuilding for every product or site.
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Dev/test/prod environments that support computer system validation (CSV) requirements and enable controlled, auditable change deployment across sites.
Key Outcomes for Medical Device Manufacturers
Complete DHR at end of production with process results, inspection data, and component lot linkage captured in real time — QA-ready without post-process compilation.
Accelerate the NCR-to-CAPA cycle with non-conformances automatically linked to production context at point of detection — no manual re-entry or delayed initiation.
Enforce change control at point of execution — approved ECOs deployed automatically to affected stations with implementation timestamp recorded and previous revisions archived.
Standardize execution across sites and product lines with workflows deployed centrally and conformance monitored from a single dashboard.
Use Cases
Real-time DHR assembly — process parameters, operator confirmations, and component lot linkage captured at each production step as work progresses; complete and QA-ready at end of run with no manual compilation required.
Non-conformance and CAPA workflow — detection triggers automatic hold and quarantine; production context (parameters, operator, equipment, component lots) captured automatically; CAPA initiated directly from NCR with full data linkage.
Equipment qualification and calibration enforcement — production workflow checks calibration and qualification status before authorizing line start; out-of-calibration equipment triggers automatic block; expiry generates proactive scheduling workflow before the due date.
Used by medical device manufacturing teams to automate compliance and maintain audit-ready records on top of Node-RED
Ready to see your Device History Record assembled in real time?
Share a sample of your production operations and quality requirements and the team will show how FlowFuse would automate traceability and DHR assembly in your environment.
