Medical device manufacturers operate in one of the world’s most highly regulated industries with peer to peer competition which is the reason why class 1,2 and 3 medical device manufacturers trust DELMIAworks as the best ERP manufacturing software for medical device manufacturing.
We help you achieve the following competitive advantages for your industry:-
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- 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
Clean Room management
DELMIAworks MES ERP Software is fully equipped with tools and capabilities for managing cost effective compliances with quality issue. These industry specific modules address:
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- 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
Seamless Tracking
Our Devices History Record (DHR) module provide medical device manufacturers to cost effectively:
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- Eliminate time-consuming, paper-based tracking & traceability systems
- Streamline product development with real-time monitoring
- Better ensure quality standards compliance
- Gain total visibility and control over the manufacturing resource planning
