AI-Powered ERP for Medical Device Manufacturing
Medical device manufacturing is one of the most heavily regulated industries. FDA 21 CFR Part 11, EU MDR, UDI requirements, and device master record management create layers of compliance that must be embedded in every ERP process. AI agents ensure nothing falls through the cracks.
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
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
Healthcare Industry Results
Medical device clients achieve 100% Part 11 compliance, 80% reduction in DHR compilation time, and zero late MDR filings. A Class III medical device manufacturer reduced FDA 483 observations from 7 to zero in 12 months after deploying Netray's compliance agents.
Ensure FDA compliance with AI—see our medical device ERP agents.
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