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.
FDA Ready
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
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:
Quality Assured
Medical technology companies need to follow strict guidelines to avoid legal issues, and Expandable ERP meets compliance requirements.
Track customer shipments back to the raw materials used to produce finished goods using data that satisfies governmental reporting requirements.
Install the structure and resources for implementing quality procedures such as tracking of incidents, corrective action, and root cause analysis.
Use the Surgical Kit module to track the location and other important data about inventory consigned to hospitals, clinics, and surgery centers.
Meet FDA 21 CFR Part 820 requirements with medical device ERP systems. Complete traceability from raw materials to patient delivery prevents costly recalls.
Is a medical device ERP worth the cost? Learn how the right system reduces material waste by 60%, speeds up production 1.5x, and lowers operational costs by 22%. Explore total cost of ownership, compliance automation savings, and how to achieve ROI in 18–36 months.
Implementing a medical device ERP system can be complex and expensive without proper planning. This article outlines the 7 most common pitfalls medical device manufacturers face—from regulatory compliance challenges to data migration, change management, and supply chain traceability. Learn actionable tips to avoid costly errors and successfully deploy an ERP system that supports your quality, operational, and regulatory goals.