ERP for Medical Device Manufacturers: Your Complete Guide to FDA Compliance in 2026
Discover how a purpose-built medical device ERP ensures 2026 FDA QMSR compliance, automates audit readiness, and reduces regulatory costs.
Quality first
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ERP for medtech manufacturing
For companies producing FDA-regulated medical equipment, diagnostic instruments, or implantable devices, Expandable ERP provides robust lot and serial number tracking. This functionality ensures compliance with industry regulations and maintains high-quality standards.
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Chosen by Leaders – Our Customers:
FDA Ready
ERP for Medical Device Manufacturers
In the medical technology arena you’re faced with some of the most challenging demands in the business world.
Compliance with the FDA and other regulatory bodies, stringent quality assurance standards, and specific reporting requirements are but a few of the obstacles you must hurdle just to throw your hat into the ring.
Include the urgency of accelerated timetables due to increased global competition and its clear that a comprehensive, integrated business system is a necessity — as early as possible.
Everything You Need
Streamlined Compliance & Precision
Expandable ERP clears your path to success with a proven solution that meets both your functional and regulatory requirements with a straightforward and cost-effective approach:
- Serial Number Tracking
- Versatile Reporting and Analytics
- Return Material Authorization (RMA)
- Consigned Inventory Management
- Product Data Management
- Multiple Units of Measure
- Lot Tracking
- Shelf Life Dating
- Quality Management
- Shop Floor Control
- Product Cost Management
- Surgical Kit Module
Quality Assured
Unique Medical Device ERP Features
Medical technology companies need to follow strict guidelines to avoid legal issues, and Expandable ERP meets compliance requirements.
Complete lifecycle traceability of serialized and lot-controlled items
Track customer shipments back to the raw materials used to produce finished goods using data that satisfies governmental reporting requirements.
The foundation of your quality system (QS) requirement
Install the structure and resources for implementing quality procedures such as tracking of incidents, corrective action, and root cause analysis.
Maintain visibility of inventory consigned to the field
Use the Surgical Kit module to track the location and other important data about inventory consigned to hospitals, clinics, and surgery centers.
FDA 21 CFR Part 11 Compliance: Complete Guide [Requirements & Implementation Steps]
Navigate FDA 21 CFR Part 11 compliance with confidence. Learn the core requirements for electronic records, avoid common audit trail gaps, and follow our five-step framework to achieve full inspection readiness.
Future-Proofing Your Medical Device Manufacturing: Emerging Trends and Innovations in ERP Systems
Upgrade your medical device ERP to drive growth. Learn how modern systems offer 89% better data accuracy, 47% faster development, and seamless compliance.