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Why does the FDA want companies to submit a URRA instead of a Use FMEA?
Автор: Medical Device Academy
Загружено: 2024-01-19
Просмотров: 995
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On our website we sell a usability procedure (SYS-048). The procedure cost is $299, and the procedure includes the following documents:
1. SYS-048 Usability Procedure
2. TMP-030 Summative Usability Study Protocol
3. TMP-040 Use-Related Risk Analysis (URRA) Template
4. TMP-041 Human Factors Usability Report Template
5. URRA Template from FDA 2022 Draft Guidance (Table 2)
➤ https://www.medicaldeviceacademy.com/...
We updated TMP-040 to match the FDA draft guidance, and the Excel spreadsheet has the same table, but no explanation is included.
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