ERP and CRM for Medical Device Manufacturers

We help medical device manufacturers retain a much more detailed picture of production, materials, workflows design revisions and end customer service and support required by FDA regulations.

FDA regulation requires you to retain a much more detailed picture of you production, materials, workflows, design revisions and end customer service and support.

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 365 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 365
  • 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 365 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​​​

""The Fullscope team was well prepared from the start. They knew our industry, and had experience in Life Sciences. Fullscope's 'sure step' implementation model was tailored to our business, ensuring success. We rely on Fullscope to help apply ongoing, cumulative updates and hot fixes for Dynamics.""

Rick Trask

Nonin Medical

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Case Study

Nonin Medical

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