Medical Device ERP Software
FDA 21 CFR Part 820, ISO 13485, and UDI-ready ERP for US medical device manufacturers — built for validation, audits, and the reality of regulated production.
Medical device manufacturers don't get the luxury of generic ERP. The FDA's Part 820 Quality System Regulation, ISO 13485, and the FDA's UDI rule together make assumptions about how your data is structured, signed, audited, and retrieved. Generic ERP either ignores those assumptions or charges six figures for a 'medical device extension' that doesn't actually align with how your QMS auditors work.
Volvsoft builds custom medical device ERP for US manufacturers whose existing system blocks audits, slows complaint investigations, or fails the validation standard. We design the data model around DHR, DMR, and DHF; build electronic signatures that hold up under FDA Part 11; and generate the UDI exports your customers and the GUDID expect. Pairs with our ISO 13485 QMS and supply chain traceability platforms.
What you get
Device Master Record (DMR) management
Versioned BOM, routing, work-instruction, and acceptance-criteria definitions per device family. Effective-dated change control built in.
Device History Record (DHR) capture
Every unit's production record — operator, equipment, lot, serial, in-process inspections — captured at the operation, not bolted on after.
UDI generation & GUDID submission
DI/PI logic for your barcode and label workflows. Direct GUDID submission with versioning.
FDA 21 CFR Part 11 electronic signatures
User authentication, signature manifestation, audit trails — validated against current FDA guidance.
Validated workflows (IQ/OQ/PQ)
Documentation, protocols, and traceability matrices delivered with the software. Built for your validation team.
Complaint, NCR, and CAPA integration
Production data feeds complaint investigations directly. Trend analysis surfaces issues before they become recalls.
Why generic ERP fails medical device
Plants we work with usually arrive after a Part 820 audit found gaps that the existing ERP couldn't close. Common patterns:
- DHR is built from spreadsheets and PDFs because the ERP doesn't model lot/serial granularity
- Engineering changes don't propagate to in-flight work orders cleanly — inspectors find effectivity violations
- Electronic signatures are bolt-on plug-ins not validated to current FDA Part 11 guidance
- UDI generation is a manual export to a third-party tool, breaking the audit trail
- Complaint investigations require multi-day data-pulls because production data is fragmented
Class I, II, and III in mind
Risk class determines validation depth and audit frequency. We adapt the architecture and documentation accordingly — Class III implants get the full risk-based validation; Class I gets the right-sized version.
- Class III — full IQ/OQ/PQ with formal risk analysis (ISO 14971)
- Class II — risk-based validation with focused OQ/PQ on critical features
- Class I — streamlined validation aligned to your QMS validation procedure
- Combination products — additional 21 CFR Part 4 and Part 211 considerations
Integration with what you already run
We rarely rip out existing systems. The medical device ERP often sits at the center, integrating tightly with QMS, MES, PLM, and customer-facing UDI catalogs.
- QMS — MasterControl, ETQ, Greenlight Guru, custom
- PLM — Windchill, Teamcenter, Aras, Arena
- MES — Aegis, Plex, Wonderware, custom
- Document — Veeva, SharePoint, Documentum
- Customer EDI — distributor and hospital ASN, lot data
Frequently asked questions
Can you provide validation documentation?
Yes. IQ, OQ, PQ protocols, validation plans, traceability matrices, and validation summary reports — delivered as part of the engagement, aligned to your QMS validation procedure.
How do you handle EU MDR alongside FDA?
Same architecture, broader compliance surface. EU MDR adds UDI-DI requirements via EUDAMED and stricter post-market surveillance data needs. The software supports both — your team configures which markets a device serves.
What about combination products?
We build for combination products (device + drug, device + biologic) — the data model handles 21 CFR Part 4 cross-applicability and the Part 211 cGMP overlay where the drug rules apply.
Is this on-prem or cloud?
Both supported. FDA-validated cloud (AWS GovCloud, Azure validated environments) is the most common deployment. On-prem available where customer or regulator requires it.
Related solutions
Other Volvsoft platforms US manufacturers commonly pair with this one.
Industries we serve
Manufacturing verticals where Volvsoft has shipped production systems for US clients.
Ready to talk to a manufacturing software team?
Book a free 30-minute call. We'll scope your platform.
- Email: sales@volvsoft.com
- Phone: +1 415-729-8811
