Design Controls and Development: Requirement

A System Approach to Medical Device Requirements for Efficient & Compliant Design and Development Through Out The Complete Product Life Cycle.

Medical Device companies face increasing product and process complexity as they seek to address the unique demands of their customers. In addition, as products include more software, health-based monitoring systems offer consumers more opportunities to take control of their health. However, companies are still managing legacy paper-based systems, or siloed electronic documents that are painful to track and assess global opportunities. They also consequently increase audit risk and product recalls.

License for Requirements enables global development organizations to drive consistency in a shared environment when capturing customer, regulatory standards and market-driven requirements. Requirements can be defined and decomposed into a hierarchy, and fulfilled through the design, implementation and testing of final products to provide traceability throughout product development.

The benefits are further extended when used with CATIA® solutions to define complex products, including their functional and logical aspects. In addition, as requirements are linked to program and project management activities, full traceability is established throughout the entire development process ensuring that the products that are developed will meet original market goals.