IEEE Standards

You can access the IEEE Standards collection online. IEEE standards are copyrighted material, so you will need your own license to view them.

• IEEE.Standards Online

SEI CMM

The Software Engineering Institute (CMM) model for Software Capability Maturity (CMM). You can visit the SEI online and obtain their documents at:

• Carnegie Mellon - Software Engineering Institute

Here's a quick overview of the five levels of maturity:

1) Initial The software process is characterized as ad hoc, and occasionally even chaotic. Few processes are defined, and success depends on individual effort.

2) Repeatable Basic project management processes are established to track cost, schedule, and functionality. The necessary process discipline is in place to repeat earlier successes on projects with similar applications.

3) Defined The software process for both management and engineering activities is documented, standardized, and integrated into a standard software process for the organization. All projects use an approved, tailored version of the organization's standard software process for developing and maintaining software.

4) Managed Detailed measures of the software process and product quality are collected. Both the software process and products are quantitatively understood and controlled.

5) Optimizing Continuous process improvement is enabled by quantitative feedback from the process and from piloting innovative ideas and technologies.

Medical Devices - FDA

Glossary of Computer Terms

DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Guidance Off-The-Shelf Software Use in Medical Devices

General Principles of Software Validation

21CFR Part 11 - Electronic Records; Electronic Signatures

To make sure you have the most recent information, you can also look at the FDA's site for medical devices at:

• Center for Devices and Radiological Health (CDRH).
• Center for Biologics Evaluation and Research (CBER - section on medical devices). CBER regulates all devices related to HIV and AIDS, as well as all blood collection, processing, etc.

In principle, the FDA Design Control requirements for software are roughly equivalent to an SEI CMM rating of 3. Although the FDA does not formally recognize the CMM, the information about Level 3 can be helpful in determining how to meet the design control requirements.