Medical Device ERP Software

Reduce Risk and Improve Compliance, Quality, and Traceability

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 device manufacturers trust our ERP software for device manufacturing .

We help you achieve the following competitive advantages for your industry:-

      • Track and trace
      • Product identification and serialisation
      • Installation Qualification (IQ) and Operations Qualification (OQ)
      • Warranty and service tracking
      • Compliance tracking
      • CAD library management

Manage Medical Device Compliance and Quality

We are fully equipped with tools and capabilities for managing cost effective compliances with quality issue .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

Seamless Tracking

Our Devices History Record(DHR) module provide 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