Medical device manufacturing companies face the traditional challenges of the electronics manufacturing industry; however, FDA regulation requires them to retain a much more detailed picture of their production, materials, workflows, design revisions and end customer service and support. If the devices contain liquids, they may also have some process manufacturing production requirements.

Microsoft Dynamics AX is an enterprise resource planning (ERP) system that helps medical device manufacturers address two distinct operational challenges: running efficient discrete production activities while maintaining FDA compliance for both operations and software. It has thousands of users worldwide, including medical device manufacturing companies, and frequently replaces Oracle and SAP; is sold only by authorized Microsoft resellers like Edgewater Fullscope; and includes core applications for financials, CRM, SCM, human resources, project management and analytics.

Microsoft Dynamics AX ERP software for medical device manufacturers supports the entire product development, production, sales and support, beginning with engineering to stock and engineering to order processes, retaining version controlled design documents to track the history of design process. Using the same change request and change order workflows, Microsoft Dynamics AX for medical device manufacturing can help improve the product design, production and after sales support by giving users an integrated framework and a clear view of the product development history.

All companies that produce regulated devices or substances must demonstrate that they can meet the processing, safety and tracking standards required by law. Fullscope’s FDA Validation Toolkit software offers tracking and managing validation activities, templates for completing the documentation required by the U.S. FDA, documentation for a vendor audit of Microsoft Dynamics AX, and consulting services to assist the manufacturer in completing the validation process.

Certain functionality is critical in medical manufacturing, and Microsoft Dynamics AX with high tech and process supports FDA compliance, engineering change orders (ECO), engineering change requests (ECR), manufacturing change orders (MCO), manufacturing change requests (MCR), document management (PDM), electronic signature, complete audit trails, device master and history records and full life cycle after sales service and support.

Next Steps

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