IQMS supplies EnterpriseIQ single-database ERP software designed specifically for medical manufacturing businesses. Our complete system handles manufacturing and financial needs while meeting all compliance and validation requirements. EnterpriseIQ is easy to implement, use, and maintain without requiring expensive third-party interfaces

Medical Expertise

Meeting Medical Device Manufacturers' Needs

IQMS offers a powerful ERP software solution tailored to systematically meet the unique challenges of the medical-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 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 IQMS for advanced capabilities that help sustain their competitive advantage.

Manage 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 ERP Tools for Success

IQMS's comprehensive single-source ERP solution provides a host of critical capabilities 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

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