Medical Devices

For companies in the medical devices industry, IFS Applications™ for Medical Devices supports the entire range of business processes from engineering of new products through manufacturing and delivery to after sales. Component-based for maximum scalability and flexibility, the solution enables companies in the industry to enhance customer relationships, speed up time to market, and achieve a faster return on investment. It also includes comprehensive supply chain and asset lifecycle management functionality. Any system working under FDA regulations -- or similar rules promulgated by various National Regulatory Agencies -- must comply with Current Good Manufacturing Practices (CGMP), which control the design, manufacturing, distribution, and servicing of medical devices. For medical device manufacturers, these rules are defined in Title 21 CFR Part 820, Quality System Regulations. IFS Applications for Medical Devices includes functionality for electronic records, electronic signatures and audit trails in line with Title 21 CFR Part 11. IFS Applications has already proven its ability to help customers comply with FDA requirements.

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