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Reduce Risk and Improve Compliance, Quality, and Traceability

DELMIAworks offers a powerful manufacturing ERP software solution tailored to comprehensively meet the unique challenges of the medical device manufacturing industry. When FDA compliance, medical device quality, and enterprise-wide traceability are critical factors of success, DELMIAworks customers rely on our customized modules to address their ever-evolving and complex needs.


Optimal Manufacturing Productivity for Healthy Profitability

Medical device manufacturers operate in one of the world’s most competitive and highly regulated industries where success can hinge on time-to-market and traceability. That’s why Class 1, 2 and 3 device manufacturers turn to our ERP software for medical device manufacturing capabilities that help sustain their competitive advantage including: 

  • Track and trace
  • Product identification and serialization 
  • Installation Qualification (IQ) and Operations Qualification (OQ)
  • Warranty and service tracking
  • Compliance tracking
  • CAD library management


Manage Medical Device Compliance and Quality

DELMIAworks medical quality suite provides tools and capabilities necessary to cost-effectively manage compliance with quality issues while facilitating internal communication and collaboration. These industry-specific modules address:

  • ISO 13485 and 9001 standards
  • Current Good Manufacturing Practice (CGMP)
  • 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
  • Product Lifecycle Management
  • Non-conforming product review and tracking


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