Medical Device ERP Challenges
Medical device manufacturers need ERP systems that enforce electronic signature requirements, maintain device history records (DHR), manage complaint processing workflows, and ensure full traceability from raw material to patient. Manual compliance processes are unsustainable as regulations tighten.
- FDA 21 CFR Part 11 requiring validated electronic records and signatures
- Device Master Record (DMR) maintenance across 1000s of SKUs
- Complaint processing within 5-day MDR timeline requirements
- UDI (Unique Device Identification) management across product families
What an ERP Needs to Support the DHR
The DHR is only as good as the transactions behind it. For each lot or serial number the ERP should hold the work order and routing, the components issued with lot or serial traceability, the operations completed and by whom, in-process and final inspection results, nonconformances and rework, and the release approval with an electronic signature. If any of these live outside the ERP, the DHR has to be stitched together from several systems.
- Lot and serial genealogy from raw material receipt to finished device shipment
- Routing steps and inspection results tied to the work order, with operator and timestamp
- Nonconformance and rework records linked to the affected lot or serial number
- Release approval captured with a Part 11 compliant electronic signature
Healthcare AI Agents
Netray's healthcare agents are purpose-built for medical device manufacturing ERP. They enforce Part 11 compliance, automate DHR generation, accelerate complaint processing, and maintain UDI compliance across all product lines.
- Automated 21 CFR Part 11 compliance with electronic signature validation
- AI-generated Device History Records from production transactions
- Complaint triage and MDR filing assistance within regulatory timelines
- UDI assignment and label verification automation
Try it here, free
Medical Device ERP Fit Assessment
Score how well your current or shortlisted ERP supports medical device manufacturing requirements including DHR generation, lot traceability, Part 11 controls, CAPA, and UDI submission.
What to Expect in Practice
Results depend on how complete your ERP transaction data is and on your validated quality system. The realistic gain is less manual compilation of each DHR and earlier detection of gaps, such as a missing lot number or an unsigned step, before a record is released. The agents prepare and check records; your quality team reviews and signs, and your validation procedures still apply.
Frequently asked questions
What is a DHR in a medical device ERP?
A DHR, or Device History Record, is the record showing that a specific lot, batch or serial number was built according to its Device Master Record. In an ERP it is assembled from the work order, material lot traceability, routing and inspection results, and the release approval.
Can an ERP generate the DHR automatically?
Partly. An ERP with lot traceability, routing and inspection transactions holds most of the data, but producing a complete, reviewable DHR usually needs configuration, a report or a quality system alongside it. AI can assemble the record and flag missing or inconsistent entries for a person to review before release.
Does the ERP itself need to be validated for Part 11?
Systems that hold regulated electronic records and signatures generally need documented validation for their intended use. Netray's agents are designed to read and prepare records with human review; you remain responsible for validating the overall system under your quality procedures.
Ensure FDA compliance with AI—see our medical device ERP agents.