Epicor Kinetic for Medical Devices: Features, Benefits & Costs

Epicor Kinetic for Medical Devices

Epicor Kinetic is a cloud, on-premise, or hybrid ERP solution from Epicor that provides medical devices companies with the tools they need to streamline operations, improve efficiency, and drive growth. With capabilities spanning Production Management, Advanced MES, Planning & Scheduling, Quality Management, and more, Epicor Kinetic 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. Epicor Kinetic 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

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

1. Quality management (ISO 13485): Epicor Kinetic 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: Epicor Kinetic 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: Epicor Kinetic 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: Epicor Kinetic 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: Epicor Kinetic 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, Epicor Kinetic offers purpose-built for make, move, and sell industries, advanced MES and production scheduling, and IoT-ready with Industry 4.0 capabilities to provide a complete solution for medical devices businesses.

Benefits for Medical Devices Companies

Implementing Epicor Kinetic can deliver significant benefits for medical devices organizations:

1. FDA-compliant design control and validation: Epicor Kinetic'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: Epicor Kinetic'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: Epicor Kinetic'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): Epicor Kinetic'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: Epicor Kinetic's integrated platform ensures that medical devices companies can achieve supplier qualification and audit management, reducing inefficiencies and improving overall performance.

Ready to evaluate Epicor Kinetic 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 Epicor Kinetic for a medical devices organization, there are several important factors to consider:

• Timeline: A typical Epicor Kinetic 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 Epicor Kinetic.

• 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. Epicor Kinetic's modern interface and guided workflows can help ease the transition for end users.

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

Pricing and Cost Considerations

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

• User count and licensing: $175–$350/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 Epicor Kinetic pricing quote.

Why Choose Epicor Kinetic for Medical Devices?

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

• Purpose-built for make, move, and sell industries helps medical devices organizations gain a competitive edge
• Advanced MES and production scheduling ensures smooth end-to-end operations
• Configurable without custom code 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 Epicor Kinetic for Medical Devices

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

• Get Epicor Kinetic Pricing — Receive a personalized cost estimate based on your medical devices requirements
• Compare Epicor Kinetic — See how Epicor Kinetic 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 Epicor Kinetic for Medical Devices?

Epicor Kinetic 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 Epicor and is widely used by medical devices companies ranging from mid-size businesses to large enterprises.

How much does Epicor Kinetic cost for medical devices companies?

Epicor Kinetic pricing for medical devices organizations requires custom quote based on modules and users. 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 Epicor Kinetic quote for your medical devices organization.

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

Implementation timelines for Epicor Kinetic 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 Epicor Kinetic support FDA 21 CFR Part 820 compliance?

Yes, Epicor Kinetic 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 Epicor Kinetic integrate with other medical devices systems?

Epicor Kinetic 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 Epicor Kinetic for medical devices companies?

The primary benefits of Epicor Kinetic 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 make, move, and sell industries and advanced MES and production scheduling to help medical devices organizations improve operational efficiency and drive growth.