Related Documents

ERP Software for Medical Device Manufacturers

For Improved Compliance, Quality and Traceability

IQMS 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, IQMS customers turn to our customized modules (such as our suite of medical quality tools including DHR) 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 EnterpriseIQ ERP software for medical device manufacturing for capabilities that help sustain their competitive advantage.

Manage Medical Device Compliance and Quality

IQMS 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:

  • 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

Seamless Tracking

The Device History Record (DHR) module allows medical device manufacturers to cost-effectively:

  • Eliminate time-consuming, paper-based tracking systems
  • Streamline product development
  • Better ensure quality standards compliance
  • Gain total visibility and control over the manufacturing process

Powerful Manufacturing Tools for Success

IQMS’ comprehensive manufacturing software and MES software provides a host of critical capabilities medical device manufacturers need to succeed, such as:

  • Lot and serial tracking and traceability
  • Installation Qualification (IQ) and Operations Qualification (OQ)
  • Warranty and service tracking
  • Compliance tracking
  • CAD library management