Welcome to the Rational Medical Devices Solution for IEC 62304
The IEC 62304 mapping is a set of pages providing links between the objectives, plans, tasks, and work products specified in the IEC 62304standard and the work tasks, work products, process roles and guidance provided by the Rational Practices. This mapping is meant to aid the development of software intended to be certified under this standard by providing links between the standard and the process assets represented within the Rational Practice library and processes.

This process content represents Best Practices for Embedded Software development in a variety of safety critical industries. It is our expectation that every deployment of this process will require customization in some form. Practices and work products may be inserted, deleted, or replaced as appropriate for your organization and your project.
Main Description
Resources icon About this configuration

Welcome to the Rational Medical Devices Solution for IEC 62304!

This configuration includes the practices, delivery process and the mapping to the IEC 62304 standard.

It also includes tool configuration assets and instructions. See Tools Setup and Configuration for more information.


Learning icon  Learning

Resources icon Resources
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The IEC 62304 standard is focused on the software development processes for medical devices, but note that the standard does not specify the processes, methodologies or the artifacts that have to be produced. There are not constraints in terms of the organizational structure and no specific lifecyle model is prescribed.

Standards Landscape

How to use the Mapping

The objectives are organized into groupings following the IEC 62304 standard. If you click on the specific objective, you will navigate to a page specific to that objective with a brief description and links to the relevant Rational Practice content.

Process assets provided within the library include:

  • Tasks - include a description of the task, a set of inputs and outputs, the identification of responsible and involve roles, and links to variance forms of guidance to aid in the performance of the task.
  • Work Products / Artifacts - are the things consumed or produced by tasks and are the tangible results of those efforts.
  • Roles - specify the responsibilities of jobs within the context of the process. Roles may be assigned to tasks as primary or optional performers.
  • General guidance - there are a number of different kinds of guidance, such as checklists, term definitions, concepts, examples, and work product templates that are provided.

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