Plex Online for Medical Devices Manufacturers

Companies manufacturing medical devices face some of the most challenging operational and regulatory demands in all of business, such as:

  • Strict adherence to precision processes and high tolerance thresholds.
  • Quality assurance requirements and product traceability/genealogy mandates.
  • Compliance with FDA/CFR guidelines.
  • Certification under ISO 9001/ISO 13485.
  • Increasing need for flexibility driven by global competition.

Whether delivering Class I, II or III medical devices, manufacturers must comply with a complex tangle of regulations and mandates, while still striving to achieve world-class quality - all while facing increasing competition from low-cost manufacturers around the globe.

Yet surprisingly, medical device manufacturers lag behind other industries in the deployment of state of the art ERP software, quality management systems, and other must-have manufacturing software solutions.

Plex Online provides a turnkey manufacturing ERP software solution for medical device manufacturers with a specific focus on comprehensive CAPA functions, supplier quality management, traceability and more. Plex Online's integrated Quality Management System, Compliance Module, and Document Management System are especially useful in meeting the complex regulatory requirements of medical device manufacturing, including 21 CFR Part 11.

QUESTIONS about how Plex Online fits for medical device manufacturers?
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