Medical device manufacturers operate under strict quality and compliance requirements. You need traceability you can prove, processes you can validate, and data you can trust across production, inventory, and quality.
Epicor Kinetic is a manufacturing ERP built to support regulated operations. With the right implementation, it helps medical device teams reduce risk, improve visibility, and run faster without losing control.
Benefits of Epicor ERP for the Medical Device Industry
Validation-Ready Processes
Medical device manufacturing requires controlled processes that can be validated and repeated. Epicor supports structured workflows, approvals, and audit trails so you can reduce manual work and lower the risk of non-compliance.
This helps teams stay consistent across sites and shift changes, even as product lines evolve.
Cloud Platform Built for Modern Manufacturing
Epicor Kinetic supports cloud deployment on Microsoft Azure, which helps teams work securely across locations and maintain business continuity.
Cloud deployment also supports collaboration and faster access to information across departments such as production, quality, purchasing, and finance.
Regulatory Compliance Support
Medical device manufacturers often need to align with regulatory expectations such as FDA requirements and controlled electronic records practices, including 21 CFR Part 11 and EU Annex 11 where applicable.
Epicor helps you maintain consistent documentation, controlled access, and traceable transactions so audit preparation is less stressful and less manual.
Strong Product Quality Controls
Quality is not a separate function in medical devices. It is part of daily operations. Epicor supports quality checkpoints, nonconformance tracking, corrective actions, and documentation discipline so quality is built into the workflow, not handled after problems appear.
Traceability Across the Full Product Lifecycle
Medical device manufacturers need reliable traceability across raw materials, components, subassemblies, and finished goods.
Epicor supports lot and serial traceability, transaction history, and genealogy-style visibility so you can respond faster to audits, investigations, and recall scenarios when needed.
Customer and Partner Expectations
Medical device manufacturers serve hospitals, clinics, distributors, and internal stakeholders, all of whom expect accuracy and responsiveness.
Epicor helps connect order management, inventory availability, and production status so your team can provide clearer answers, fewer delays, and better service without relying on spreadsheets.
KINETIC ERP
Key Epicor Kinetic Features for Medical Device Manufacturing
A custom ERP solution simplifies and optimizes business processes, from stock management to medical equipment distribution. It eases management team workloads and boosts productivity.
Global Operations
Support multi-site teams with consistent processes, permissions, and reporting across locations. Keep data aligned as you expand products, plants, or regions.
Traceability and Audits
Track lot and serial history across materials, subassemblies, and finished devices. Respond faster to audits, investigations, and recall situations with cleaner records.
Cost Management
Capture real costs across materials, labor, and production so margins are based on facts, not guesses. Improve decision-making when product mix and demand change.
Product Life Cycle Management (PLM)
Manage product data, revisions, and change control so teams build from the correct version every time. Reduce risk from outdated documentation and uncontrolled changes.
Quality Management System (QMS)
Support inspections, nonconformances, and corrective actions inside daily workflows. Keep quality tied to production instead of handling issues after the fact.
FDA, cGMP, ISO, SOX Compliant
Support controlled access, audit trails, and structured records needed in regulated environments. Compliance depends on setup and governance, but Epicor provides the foundation.
Rapid Configuration
Configure workflows and screens to match controlled processes without over-customizing. This helps teams adapt while staying on an upgrade-friendly path.
Document Control and Regulatory Compliance
Link documents to parts, jobs, and transactions so records are easy to find and consistent. Reduce manual document chasing during audits and internal reviews.
Epicor Kinetic for Medical Devices: A System That Grows with You
Epicor Kinetic is built for manufacturers that need both control and agility. In medical devices, the challenge is not just producing more. It is producing more while staying compliant, traceable, and consistent.
With Epicor Kinetic, you can:
- Improve visibility into production and inventory in real time
- Reduce manual work that creates quality and compliance risk
- Standardize processes without losing operational flexibility
Meet Complex Industry Requirements and Drive Innovation
Reduce your risk of non-compliance with validation services, advanced traceability, and quality control, including FDA CFR 21 Part 11 and EU Annex 11.
- Improve your validation process with expert advice
- Take advantage of cloud-based architecture with Microsoft Azure to stay on top of evolving industry requirements
- Leverage global expertise to grow internationally
