This scenario is built on the tools and capabilities of our Systems and Software Engineering solution. Importantly for medical devices, this supports full traceability, history and auditing throughout the lifecycle.

Practices are developed in Rational Method Composer, which allows bi-directional linking between tools and process. This guidance is surfaced in the tools, so practitioners have what they need, when they need it. Tool enforcement is aligned with and based on method descriptions. The plans, work items and rules for tools are generated from, aligned with, and traced to the method description. The process and practices are therefore easy to tailor and maintain.

The set of products supports traceability, security, history and full auditability across the entire lifecycle.

Main roles:

• Project Manager
• Requirements Engineer

In this demonstration, we have shown how we can support you in developing your products using our tailored practice guidance and tools. This is part of our ongoing work to provide such tailored guidance and support into specific industries

In summary, IBM Rational’s solution for Medical Devices automates the building of structures and dependency relationships to:

• Support regulatory compliance, including auditing of process and products
• Manage increasing complexity
• Ensure designs and products meet market demands and industry requirements
• Perform effective impact and change analysis across different disciplines
• Enable collaboration across the entire development organization