You can access the IEEE Standards collection online. IEEE standards are
copyrighted material, so you will need your own license to view them.
The Software Engineering Institute (CMM) model for Software Capability
Maturity (CMM). You can visit the SEI online and obtain their documents at:
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
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
General Principles of Software
21CFR Part 11 - Electronic Records;
To make sure you have the most recent information, you can also look at the FDA's site for medical devices at:
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.