Recognized standard
SW87:2012
FDA recognition 13-35 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-35 |
|---|---|
| Designation | SW87:2012 |
| Title | Application of quality management system concepts to medical device data systems |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Jan 15, 2013 |
| Scope (excerpt) | This recommended practice provides information that will allow the medical device data system manufacturer to implement a quality management system that is commensurate with the risk presented by the device, the complexity of device and manufacturing processes, and the complexity of organization. |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: