Medical Devices

IFS Applications simplifies compliance with regulatory requirements with a fully integrated, paperless system that supports your company through all phases of the product and customer lifecycle. At the same time, IFS Applications supports business-critical processes, enabling you to get your products to market more quickly, realize a faster return on your investment, and enhance customer service.

Simplify regulatory compliance

IFS’ System Validation Kit saves you time and money by preparing you to complete the FDA and/or ISO system validation process as part of the system implementation. Integrated document management and security features allow you to better track audit-related documentation and expedite approval processes while meeting the FDA’s standards for electronic records and electronic signatures under 21 CFR Part 11.

IFS Applications supports the requirements of 21 CFR Part 820, Quality System Regulation, including:

• Integrated engineering design, purchasing, and part availability controls.
• Integrated plant and equipment maintenance, service management, quality management, and complaint tracking.
• Full lot and serial number traceability.
• Device master records (DMRs), device history records (DHRs), and quality system records (QSRs). 

In addition, IFS’ Sarbanes-Oxley solution makes it easier to comply with corporate governance laws such as the Sarbanes-Oxley Act in the United States.

Shorten time-to-market

As a fully integrated system, IFS Applications enables real-time collaboration among Sales, Engineering, and Manufacturing during product development. Engineers can get direct, instant feedback from Manufacturing and After-Sales on product design issues, and can approve and implement design changes much more quickly. This results in higher-quality products and faster time-to-market.

Get faster payback

In the medical devices industry, high R&D costs and extreme price pressures can leave you little time in which to earn back your initial investment. That’s why IFS Applications is designed for rapid payback. With IFS software, you can get your products to market faster and make your manufacturing and distribution processes more efficient. IFS’ service-oriented architecture provides for a fast, step-by-step implementation process that ensures rapid payback both after the initial deployment and with each additional component that you install.

Increase customer satisfaction and loyalty

IFS’ medical devices solution integrates enterprise resources planning (ERP) and customer relationship management (CRM), helping you to increase revenue by shortening the sales cycle, improving the delivery of services after the sale, and increasing customer satisfaction and loyalty. Both sales and service people have instant access to information on customers, devices, service contracts, and spare parts. And they can use mobile devices such as PDAs to work online or offline, no matter where they are, and stay fully in sync with the back office.