SYSPRO for Medical Devices: Features, Benefits & Costs

SYSPRO for Medical Devices

SYSPRO is a cloud, on-premise, or hybrid ERP solution from SYSPRO that provides medical devices companies with the tools they need to streamline operations, improve efficiency, and drive growth. With capabilities spanning Financial Management, Distribution, Manufacturing, Inventory Management, and more, SYSPRO addresses the unique challenges facing today's medical devices organizations.

Medical Devices companies face increasing pressure around FDA regulatory compliance and validation, device traceability (UDI), design control and change management. SYSPRO provides purpose-built functionality to help organizations overcome these challenges while maintaining compliance with standards such as FDA 21 CFR Part 820, ISO 13485, EU MDR.

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Key Features and Modules for Medical Devices

SYSPRO offers a comprehensive set of features tailored for medical devices operations:

1. Quality management (ISO 13485): SYSPRO provides robust quality management (iso 13485) capabilities that help medical devices organizations manage their quality management (iso 13485) processes more effectively, with real-time visibility and automation to reduce manual effort.

2. Device history record: SYSPRO provides robust device history record capabilities that help medical devices organizations manage their device history record processes more effectively, with real-time visibility and automation to reduce manual effort.

3. CAPA management: SYSPRO provides robust capa management capabilities that help medical devices organizations manage their capa management processes more effectively, with real-time visibility and automation to reduce manual effort.

4. Document control: SYSPRO provides robust document control capabilities that help medical devices organizations manage their document control processes more effectively, with real-time visibility and automation to reduce manual effort.

5. Supply chain: SYSPRO provides robust supply chain capabilities that help medical devices organizations manage their supply chain processes more effectively, with real-time visibility and automation to reduce manual effort.

Beyond these core modules, SYSPRO offers purpose-built for manufacturers and distributors, AI-driven insights (SYSPRO Harmony), and low-code platform for customization to provide a complete solution for medical devices businesses.

Benefits for Medical Devices Companies

Implementing SYSPRO can deliver significant benefits for medical devices organizations:

1. FDA-compliant design control and validation: SYSPRO's integrated platform ensures that medical devices companies can achieve fda-compliant design control and validation, reducing inefficiencies and improving overall performance.

2. Complete device traceability with UDI support: SYSPRO's integrated platform ensures that medical devices companies can achieve complete device traceability with udi support, reducing inefficiencies and improving overall performance.

3. Automated CAPA and complaint management workflows: SYSPRO's integrated platform ensures that medical devices companies can achieve automated capa and complaint management workflows, reducing inefficiencies and improving overall performance.

4. Electronic device history records (eDHR): SYSPRO's integrated platform ensures that medical devices companies can achieve electronic device history records (edhr), reducing inefficiencies and improving overall performance.

5. Supplier qualification and audit management: SYSPRO's integrated platform ensures that medical devices companies can achieve supplier qualification and audit management, reducing inefficiencies and improving overall performance.

Ready to evaluate SYSPRO for your medical devices business? Get a personalized pricing estimate based on your specific requirements, or connect with a certified implementation partner who specializes in medical devices.

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Implementation Considerations

When implementing SYSPRO for a medical devices organization, there are several important factors to consider:

• Timeline: A typical SYSPRO implementation for medical devices companies takes 3–12 months, depending on the scope of modules deployed and degree of customization required.

• Data migration: Medical Devices organizations often have complex data structures spanning quality management (ISO 13485), device history record, CAPA management that must be carefully mapped and migrated to SYSPRO.

• Regulatory compliance: With medical devices regulations including FDA 21 CFR Part 820 and ISO 13485, the implementation must ensure all compliance requirements are configured from day one.

• Change management: Training and change management are critical for adoption. SYSPRO's modern interface and guided workflows can help ease the transition for end users.

• Integration requirements: Most medical devices companies need SYSPRO to integrate with existing systems. SYSPRO supports this through open APIs and pre-built connectors, though integration complexity should be scoped early.

Pricing and Cost Considerations

SYSPRO pricing for medical devices companies requires custom quote based on modules and deployment. The total cost of ownership depends on:

• User count and licensing: $100–$300/user/month for cloud subscriptions
• Modules selected: Medical Devices-specific modules such as quality management (ISO 13485), device history record, CAPA management may require additional licensing
• Implementation services: Professional services for configuration, customization, data migration, and training
• Ongoing costs: Annual maintenance, support, and cloud hosting fees

For a detailed cost estimate tailored to your medical devices requirements, get a custom SYSPRO pricing quote.

Why Choose SYSPRO for Medical Devices?

SYSPRO stands out as a strong ERP solution for medical devices companies for several key reasons:

• Purpose-built for manufacturers and distributors helps medical devices organizations gain a competitive edge
• AI-driven insights (SYSPRO Harmony) ensures smooth end-to-end operations
• Strong bill of materials and production scheduling supports growth and geographic expansion
• Industry-specific functionality for quality management (ISO 13485), device history record, CAPA management addresses the unique needs of medical devices businesses
• Compliance with FDA 21 CFR Part 820 and ISO 13485 is built into the platform

Get Started with SYSPRO for Medical Devices

Ready to move forward? Here are your recommended next steps:

• Get SYSPRO Pricing — Receive a personalized cost estimate based on your medical devices requirements
• Compare SYSPRO — See how SYSPRO compares to other ERP solutions for medical devices
• Define Your ERP Requirements — Use our free tool to build your medical devices ERP requirements checklist

Frequently Asked Questions

What is SYSPRO for Medical Devices?

SYSPRO for Medical Devices is a cloud, on-premise, or hybrid ERP solution designed to help medical devices organizations manage their core business processes including quality management (ISO 13485), device history record, CAPA management, document control. It is developed by SYSPRO and is widely used by medical devices companies ranging from mid-size businesses to large enterprises.

How much does SYSPRO cost for medical devices companies?

SYSPRO pricing for medical devices organizations requires custom quote based on modules and deployment. Total cost depends on the number of users, modules selected (such as quality management (ISO 13485) and device history record), and implementation requirements. Get a personalized SYSPRO quote for your medical devices organization.

How long does it take to implement SYSPRO in a medical devices organization?

Implementation timelines for SYSPRO in medical devices typically range from 3 to 12 months, depending on the complexity of operations, number of modules, and extent of customization required. A phased approach is often recommended to reduce risk and accelerate time to value.

Does SYSPRO support FDA 21 CFR Part 820 compliance?

Yes, SYSPRO includes features and configurations that support compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR. The platform provides audit trails, reporting tools, and process controls that help medical devices organizations meet their regulatory obligations. Implementation partners can further customize compliance workflows to match specific requirements.

Can SYSPRO integrate with other medical devices systems?

SYSPRO offers robust integration capabilities through APIs, middleware, and pre-built connectors that enable connectivity with other medical devices systems including specialized quality management (ISO 13485) software, CAPA management platforms, and third-party applications. This ensures medical devices companies can maintain a connected technology ecosystem.

What are the main benefits of SYSPRO for medical devices companies?

The primary benefits of SYSPRO for medical devices companies include fda-compliant design control and validation, complete device traceability with udi support, and automated capa and complaint management workflows. The platform also provides purpose-built for manufacturers and distributors and AI-driven insights (SYSPRO Harmony) to help medical devices organizations improve operational efficiency and drive growth.