Recognized standard
TIR 36:2007
FDA recognition 13-33 · AAMI · Software/Informatics
Key facts
| Recognition number | 13-33 |
|---|---|
| Designation | TIR 36:2007 |
| Title | Validation of software for regulated processes |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Software/Informatics |
| Date of entry | Jan 15, 2013 |
| Scope (excerpt) | Applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, and complaint handling or to automate any other aspect of the quality system as defined by the Quality System Regulation (21 CFR 820). In addition, it applies to… |
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: