Best ERP for Medical Device Manufacturing: Quality, Compliance and Cost Control

Medical device manufacturers operate in one of the most tightly regulated industries in the world. Compliance is not an option; it is central to operations.

Whether it is FDA CFR 21 Part 11, EU Annex 11, ISO 13485, or Health Canada requirements, documentation, audit trails, and traceability must be built into every process. 

At the same time, manufacturers must manage complex supply chains, respond to demand variability, and bring products to market faster than ever.

This is even more challenging when dealing with multiple production modes, contract manufacturing organizations (CMOs) and original equipment manufacturers (OEMs). 

A manufacturing system like Epicor Kinetic ERP brings all operations under one roof. We’re talking: 

• Compliance 
• Production 
• Inventory management 
• Quality control 
• Reporting 

Kinetic enables real-time visibility, automated controls, and standardized processes that help manufacturers stay competitive without risking non-compliance.

Automatically capture and organize all production data related to each device. From materials used to operator activity, eDHR ensures every step is recorded and audit ready. 

Connect quality control to every process: procurement, production, and shipping. Catch issues early, document actions, and stay aligned with compliance requirements.

Track every component and finished product by batch or serial number. This supports fast, accurate recalls and full traceability from suppliers to end users.

Meet compliance standards like FDA CFR 21 Part 11 with secure electronic approvals. Every signature and change are time-stamped, traceable, and protected from tampering.

Maintain accurate inventory levels and prevent shortages with real-time stock visibility. Support just-in-time (JIT) operations and optimize warehouse space.

Medical device manufacturer Axelgaard chose Epicor Kinetic to streamline operations, improve inventory control, and maintain FDA compliance.  

But let’s remember, no two medical device manufacturers operate the same way. Some build complex capital equipments, others produce high-volume consumables. Many work with OEMs or rely on CMOs. That’s why flexibility and adaptability are so important when choosing an ERP for medical device manufacturing.

Epicor Kinetic offers deep customization capabilities that let you tailor the system to your workflows, compliance needs, and production models. Whether you need custom reports, role-based dashboards, or unique validation flows, the platform adapts without heavy coding or workarounds. 

This flexibility also extends to mixed-mode manufacturing. Epicor Kinetic supports make-to-stock, make-to-order, and engineer-to-order operations, often within the same facility. That means your medical device manufacturing software grows with you as your product lines and partnerships evolve. 

In an industry where every delay or error lead to serious consequences and lost revenue, efficiency is everything. Choosing the best ERP for medical device manufacturing cuts operational costs. Epicor Kinetic reduces manual error and redundant work through automation, eliminates silos, and surfaces real-time insights.  

It also enables medical device manufacturers to: 

• Automate manual processes like data entry, document management and quality checks 
• Identify bottlenecks early with real-time production and inventory dashboards 
• Improve forecasting and planning across procurement, manufacturing, and distribution 
• Optimize resource use by aligning demand with inventory and capacity 

Instead of reacting to issues after they happen, manufacturers can take proactive control over time, cost, and quality. The result? Faster time to market, fewer errors, and better margins. 

Medical device manufacturers face some of the strictest regulatory requirements in manufacturing. Non-compliance is costly, can stop production or prevent market access entirely. 

Epicor Kinetic helps manufacturers meet key standards such as: 

• FDA 21 CFR Part 11 by managing electronic records and signatures with secure access, version control, and traceability. 

• ISO 13485 by integrating quality processes and documentation into day-to-day operations. 

• EU Annex 11 by supporting electronic system validation and audit readiness for European markets. 

• Health Canada requirements through full traceability and real-time access to production data. 
• With Epicor Kinetic as your ERP software for medical device manufacturing, you manage compliance proactively. Every workflow, approval, and report include it. It reduces the risk of failed audits, recalls, or delayed market entry. 

Not all ERP solutions are built for the realities of medical device manufacturing. To choose the best medical device ERP software, look beyond basic features. Focus on capabilities that fit your industry. 

Here’s what to prioritize: 

• Built-in compliance support: Can this medical device ERP system meet FDA 21 CFR Part 11, ISO 13485, and Health Canada regulations out of the box? 
• Lot and serial traceability: Is it easy to track components and finished goods from suppliers to patients? 
• Integrated quality management: Can it integrate quality processes be embedded into production, instead of tracking them after the fact? 
• Flexibility and scalability: Can your medical device ERP software adjust to your manufacturing methods, partnerships (OEMs, CMOs), and future growth? 
• Real-time data and reporting: Does it provide actionable insights to manage costs, risks, and performance? 

Epicor Kinetic meets all these needs and more. It is a trusted choice for medical manufacturers who want to grow without compromising quality or compliance. 

Choosing the right ERP is critical, and so is choosing your implementation partner. 

At EC Solutions, we help medical device manufacturers use their Epicor Kinetic ERP system effectively. Our team understands your regulatory landscape, your operational complexity, and the level of precision your business demands. 

As an Epicor Gold Partner, we offer: 

• Deep industry expertise specific to the MedTech sector 

• Tailored configurations for OEMs, CMOs and mixed-mode manufacturers 

• Local support across Canada with fast, responsive service 

• Proven ERP project delivery for compliance-focused environments 

When you collaborate with EC Solutions, you’re not just implementing ERP software; you’re building a foundation for quality, compliance, and long-term growth.