1020357
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 4, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Framingham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |