510(k) Tip - Schedule your URRA and the HF protocol before design freeze
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- เผยแพร่เมื่อ 9 ส.ค. 2023
- This week's 510(k) tip is to make sure that you include the scheduling of your use-related risk analysis (URRA) and the draft summative usability protocol before your design freeze. This will make sure you have time to ask questions about human factors testing during a pre-submission supplement meeting with the FDA before you being your verification and validation testing.
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