DELMIAWorks (formerly 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, Medical Device manufacturers rely on DELMIAWorks 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 DELMIAWorks 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
Automate the Device History Record — DHR — with Complete Record of the Production History
The DELMIAWorks Device History Record (DHR) module automates the process of collecting a complete record of the production history of a medical device from the design and quoting process, through production, to the end of the life of the device, reducing the abundance of paper documents and eliminating manuals errors. The DHR module is fully integrated into DELMIAWorks ERP, ensuring that quality is built into every step of the manufacturing process.
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
Manufacturing ERP Solutions
A single collaborative platform connecting the entire design to manufacturing process
Quality Management
A powerful and flexible QMS software system to help manufacturing companies control and comply with the most stringent quality standards
Manufacturing Traceabilty
A complete Manufacturing Track and Trace System
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DELMIAWorks solutions solve your manufacturing challenges by connecting the entire design to manufacture process.