01
Electronic device history records
Replace paper DHRs with validated electronic records that capture operator actions, process parameters, and inspection results in real time.
Regulated discrete · Production Module
Validated production tracking for FDA-regulated manufacturing.
Medical device production demands validated processes, electronic batch records, and full traceability from incoming material through sterilization and release. Dynamism Factory provides the execution layer that keeps production moving while maintaining 21 CFR Part 820 compliance.
Capabilities
What the Production module does for Medical Devices.
Track work orders, routing progress, bottlenecks, and delivery risk from release through shipment.
02
Process parameter enforcement
Automatically verify that validated process parameters (temperature, pressure, time) are within spec before allowing operators to proceed.
03
Integrated CAPA workflow
Route non-conformances directly into CAPA workflows with root cause analysis templates, effectiveness checks, and audit-ready documentation.
04
Component-level lot traceability
Trace every component, material lot, and sub-assembly through the full build history with one-click genealogy reports.
Why it matters
Where Medical Devices teams get stuck.
These problems look operational on the surface, but they are usually coordination and information problems underneath.
01
Paper-based DHRs create bottlenecks at every step and make post-production review take weeks.
02
CAPA and non-conformance workflows live in disconnected systems, delaying resolution.
03
Validated process parameters are checked manually, creating risk of out-of-spec production.
04
Lot traceability across components, sub-assemblies, and finished goods is fragmented.
Use cases
How teams use Production in Medical Devices.
Real workflows that connect the module to the problems above.
01
Class III device batch release
Execute a complete batch record with automated parameter verification, in-process inspections, and electronic sign-offs that satisfy FDA review.
02
Field safety corrective action
When a field issue is reported, trace the affected lot back through every component, supplier, and process step within minutes.
03
Audit-ready production records
Present complete, searchable production records to FDA auditors without pulling paper files from storage.
Explore further
Related pages.
Industry
Medical Devices
Documentation, quality records, and lot-level traceability need clean handoffs between estimating, production, and compliance teams.
View industry page →
Module
Production
Track work orders, routing progress, bottlenecks, and delivery risk from release through shipment.
View module page →
American Dynamism
Better Production for American Medical Devices manufacturers starts here.
Start with the workflows that create the most drag today. American manufacturers should not have to settle for software that was not built for the complexity of their work.