ERP and Manufacturing Software for Medical Device Manufacturers’

IQMS offers a powerful Manufacturing ERP software tailored to systematically meet the unique challenges of the medical device manufacturing industry. Customized modules, such as Quality Medical and DHR, exemplify IQMS’s commitment to addressing the ever-evolving and complex needs of the industry with solutions that make medical device manufacturers’ jobs easier.

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 EnterpriseIQ ERP Software for advanced Medical Manufacturing capabilities that help sustain their competitive advantage.

Manage Medical Device Compliance and Quality

IQMS Quality Medical provides tools and capabilities necessary to cost-effectively manage compliance with quality issues while facilitating internal communication and collaboration. This industry-specific module addresses:

• 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 process
• 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 ERP Tools for Success

IQMS’s comprehensive Manufacturing ERP solution provides a host of critical capabilities medical device manufacturers needed to succeed, such as:

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