Healthy manufacturing productivity for Medical Devices

Medical device manufacturers operate in one of the world’s most competitive and highly regulated industrys, where success can hinge on time-to-market and traceability. That’s why Class 1, 2 and 3 device manufacturers turn to our software for medical device manufacturing for capabilities that help sustain their competitive advantage. SYSPRO combines regulatory experience with proven manufacturing capabilities to provide medical device manufacturers with tools to increase competitive advantage, sustain high quality standards, collaborate effectively with the supply chain, and maximize customer satisfaction.

SYSPRO helps ensure Medical Device quality and compliance

  • TS13485 and ISO 9001 standards
  • CFR and FDA requirements
  • Up-front risk assessment
  • Secure electronic signature and document control to comply with 21 CFR Part 11
  • Complete audit trail of manufacturing processes
  • Comprehensive Corrective Action/Preventive Action (CAPA) and Process/Product PQ functionality
  • Non-conforming product review and tracking

 

SYSPRO helps our customers in all areas

You’ll better manage costs and margins while adhering to the strict quality and regulatory requirements of your industry.

  • Lot Tracking
  • Serial Number Tracking
  • Shelf Life Dating
  • Multiple Units of Measure
  • Multi-currency Accounting
  • Product Data Management
  • Product Cost Management
  • Shop Floor Control
  • Business Intelligence and Analytics
  • Versatile Inquiries and Reporting
  • Quality Management
  • Return Material Authorization (RMA)

SYSPRO Customers

RhythmLink erp-medical

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