ERP Software for Medical Device Manufacturers

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

Microsoft Dynamics AX ERP software for medical device manufacturers address two distinct operational challenges:

  • Running efficient discrete production activities while
  • Maintaining FDA compliance for both operations and software

End-to-end Operational Improvements

  • Support the entire product development, production, sales and support, beginning with engineering to stock and engineering to order processes
  • Retain version controlled design documents to track the history of the design process
  • Use the same change request and change order workflows to improve your product design, production and after sales support

Give users an integrated framework and a clear view of the product development history          

Maintain FDA Compliance

If you produce regulated devices or substances, you must com​ply with the processing, safety and tracking standards required by law or face serious fines. The Edgewater Fullscope FDA Validation Toolkit offers tracking and managing validation activities to help,  including:

  • Templates for completing the documentation required by the U.S. FDA
  • Documentation for a vendor audit of Microsoft Dynamics AX
  • Consulting services to assist you in completing the validation process

More Efficient Production Planning

Certain functionality is critical in medical device manufacturing, and Microsoft Dynamics AX with its high tech and process capabilities 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
  • Full life cycle after sales service and support​​​

​Learn more about our discrete and process manufacturing experience in these industries:

Download ERP for Medical Devices Fact Sheet
Contact Medical Device ERP Experts
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