Rational electronics industry solutions

IBM Rational provides an integrated, end-to-end traceable solution to help medical device companies improve their processes, automate FDA document generation and bring innovative, safe, and high-quality products to market – differentiated through software.

IBM Rational can help your organization to:

• Apply sound systems engineering principles to build the right product at the right time that meets the ever changing requirements of the marketplace
• Enable traceability from requirements through implementation (code) and test
• Apply FDA CFR 21 Part 11 compliant electronic signatures for signing off requirements baselines and change approvals
• Unify communications and collaboration across globally distributed organizations, including partners and suppliers
• Implement an integrated change management process across the product lifecycle for both hardware design and software development
• Achieve greater reuse of existing architectures
• Establish sound risk management practices that address risks early and throughout the product development lifecycle by continually validating, simulating, and verifying design and implementation
• Generate documentation automatically from the design for FDA submission
• Establish quality management best practices that reduce testing time and improve overall product quality through model-driven testing and automation