Welcome

Thank you for your interest in the Medical Devices Solution Beta Program. The IBM Rational Medical Device Solution is a comprehensive solution consisting of process, methods, tools and service offerings designed and tested together to meet the needs of organizations and teams developing and maintaining medical devices.

Solution Vision

The IBM Rational Medical Device solution it is built on a solid foundation - The IBM Rational Systems and Software Engineering Solution. The following figure provides a high level overview of the IBM Rational Systems and Software Engineering solution.

The solution consists of processes, methods, and tools that deliver an integrated solution with the following core capabilities:

Process Management

Capture, structure, tailor and communicate processes and best practices. A rich library of process assets that can be used as-is or tailored to meet the particular needs of each project/team. Executable work item templates based on and linked to process descriptions support execution of the methods with in-context guidance and traceability to standards and regulations to simplify compliance and increase productivity.

Requirements Management

Capture, structure, validate, query, report and manage changing requirements all the way from stakeholder/market needs through technical system requirements to detailed subsystem and component requirements to ensure your team build the right thing right.

Architecture & Design

Model functional and physical architectures from system level through subsystem to unit design to ensure a common understanding of the design of the system and to reduce risk through early validation of requirements and design via model execution.

Quality Management

Achieve quality by design through early and frequent testing from unit tests through integration test to final validation.

Collaboration, Planning and Reporting

Manage plans and work assignments, based on and linked to documented processes and methods so everyone on the team knows what has been done and what remains to be done throughout the system lifecycle to provide visibility and reduce barriers to success.

Configuration and Change Management

Ensure proper version management of all lifecycle assets throughout the system lifecycle through configuration item identification, change management, configuration status accounting and configuration audits.

The Medical Devices solution specializes and extends the core Systems and Software Engineering solution with tailored process and methods, tool configuration assets and artifact and report templates to meet the specific needs of medical device industry. The vision for the Medical Devices solution is to provide a complete, exemplar solution to help our customers in the medical device industry:

• Accelerate time to value and return on investment with Rational tools
• Improve product quality
• Reduce time to market
• Reduce development and maintenance cost
• Simplify regulatory approval and compliance

What's in the beta - and what is not in the beta

This beta release of the Medical Devices Solution focuses on design control capabilities aligned with 21 CFR 820 (FDA Quality Systems Regulation), Current Good Manufacturing Processes, and IEC 62304 including:

• Developing and maintaining the Design and Development Plan
• Requirements Management
• Configuration and Change Management
• Risk Management
• Project Planning and Tracking
• Formal Reviews
• DOORS Intended Use Validation

This beta solution consists of DOORS 9.4, Rational Team Concert 4.0, and this method website generated from Rational Method Composer 7.5.2. The method website provides all of the process assets required to configure the tools and evaluate the solution using exemplar workflows describing who does what, when and how throughout product lifecycle.

Future solution increments will add:

• Model Based Systems Engineering (MBSE)
• Safety, Reliability and Hazard Analysis including Fault Tree Analysis
• Model Driven Development (MDD) of embedded software
• Test Management
• Reporting
• Intended use validation for the complete solution

We do provide method content addressing these areas as part of this early access beta, however we are not asking you to install Rational Rhapsody or Rational Quality Manager for this evaluation. Feedback on these areas are certainly encouraged to help us craft the best possible solution.

Objectives of this early access Beta

The objectives of this early access beta are to provide selected customers and business partners with the opportunity to gain early experience with and influence the development of the new solution. Specific goals:

• To validate solution increment capabilities and usage scenarios;
• To provide direct customer input to the solution development team;
• To influence development of future increments

How to evaluate the beta

This method website is intended to guide you through your evaluation. To the left you will see the navigation window that contains three "drawers":

• IEC62304: Provides a navigation tree to view process and method content related to the international standard for developing medical device software.
• Design Control Solution: Provides a navigation tree to view process and method content related to FDA Quality System Regulations for developing medical devices.
• Evaluation Guidance: Provides a guide to evaluating the method content and enabling tool support for the early access beta.

To continue your evaluation start by reviewing the basic concepts and tool installation and configuration guidance under the "Getting Started with the Evaluation" node on the left.

Once you complete the tool installation and configuration you can use the Change Mangement scenario and the Process Guidance Evaluation scenario under the Evaluation Scenarios node to walk through the key aspects of the solution. Of course you should feel free to explore other areas of the method website. All feedback is most welcome! The Evaluation Feedback Instructions provides guidance on submitting feedback to the development team.

Once again, thank you for taking the time to help craft the best possible solution to meet YOUR needs.