Medical Device Manufacturing

Kitron ERP & MES system for manufacturing medical instrumentation

The medical device manufacturing industry faces stringent requirement and challenging quality assurance requirements for the production of products that faces the FDA and other regulatory standards, while facing the requirement to stay on schedule. At the same time, there is a constant need to reduce costs while increasing profitability and staying competitive.

Therefore, the success in this industry depends on the ability to produce excellent products and the ability to track control processes in order to develop and manufacture products that stands with the highest quality standards.

The Kitron ERP & MES system is the proven solution that meets regulatory and market requirements. The Kitron system provides an ERP solution integrated with the MES system and includes vertical capabilities to manage complex manufacturing processes while complying with FDA quality requirements.

• Batch number management and serialization - Full tracking of serial numbers and batch numbers at all levels.

• Engineering Change Management ECO - Tracking product life cycle from design to sale.

• Full system for quality management - Compliance with regulatory standards, including FDA requirements.

• Improved delivery times - using sophisticated MRP to reduce inventories and manage production lines to the level of JIT.

• Customer Management and Service - Manage your customer relationship management and full service after sales system more effectively.

• Document Management - Enables storage and drawing out documents in one central location with the ability to manage permissions, version management, report number management, document template management, surveillance, etc.

• Control and analysis of quality data - Perform statistical control and analysis of the quality of the production process in real time in order to prevent defects in advance. Based on the investigation of capability and process performance, supervision of the process and recognition of the change in the process and identification of the reasons for the special variability.

• Production floor management - central and comprehensive control of production management by each station or employee, and monitors the progress of the work on the order lines.

• Automatic production planning - Global planning for maximum efficiency and minimum lateness, by delivery times to minimum production floor inventory, order priorities and minimum inventory action, etc.

For the medical device manufacturing industry, Kitron ERP & MES provides a powerful and flexible solution with the ability to support a growing and developing company by expanding the proposed solution and directly improving profitability by planning and using existing resources.