We will login to RTC as a Project Manager working on an Infusion Pump. Double-click the Rational Team Concert (RTC) shortcut:

Login as pete/pete, the project manager.

Navigate to Pete’s web dashboard clicking on Project Dashboards -> Infusion Pump in the upper left corner.

Right-Click on the Welcome Page for Design Control in the Booksmarks widget, and choose Open In New Tab.

Navigate to the newly opened tab.

Here, we can see the practices content within the context of the work items and work products being developed.

The navigation tree shows many perspectives that you may use to browse through the information; for example by role, by task or by process.

Here, we have information on Design Control Concepts as described by the US FDA Code of Federal Regulations (CFR).

Click on Design Control Concepts

Here, we have information on tool setup which includes tool specific templates for work instructions, specifications, etc. Click on Getting Started -> Tool Setup and Configuration.

Part of this information includes reference to Intended Use Validation (IUV) practices. You can see that this page includes a link to a video on the topic. For an introduction, Click on Getting Started -> Intended Use Validation with DOORS.

Also included with the Design Control offering is a set of practices for IEC 62304, a worldwide standard for medical device software development. We can see here how to meet the objectives for Risk Management according to IEC 62304. In the IEC 62304 top level section, navigate to IEC 62304 Objectives -> IEC 62390 SW Risk Management Process.

This type of practice information is also available from within the tools using context specific links. Where appropriate, it also links to tool content. The practice information is then readily accessible to all users, reducing both search time and risk of missing tasks.