The three main process areas are:  

• Design Control Solution: IBM Rational's set of practices to support medical device companies in developing in compliance with FDA guidance. The Design Control practices use the terminology found in the FDA Guidance for medical device manufacturers.
• Intended Use Validation: Provides guidance on the execution of Intended Use of Fit to Purpose Validation.
• IEC62304: a standard for developing software for medical devices This includes significant detail, including, for example, how to meet the objectives on Risk Management.

For specific tool guidance see the More Information section.