luloo117117
17th March 2009, 05:15 PM
Can we use the data in intertek or TUV lab testing report as bench testing data for 510(k) applications?
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View Full Version : Can we use the data in intertek or TUV lab testing report as bench testing data? luloo117117 17th March 2009, 05:15 PM Can we use the data in intertek or TUV lab testing report as bench testing data for 510(k) applications? Le Chiffre 18th March 2009, 10:30 AM Are you asking whether third-party testing can be included under the "Performance Testing – Bench" section of the 510(k)? I guess it depends what testing Intertek or TUV did for you. luloo117117 18th March 2009, 12:53 PM One example, Intertek or TUV lab they tested my device vibration test. Do we need to test it again? or can just indicate in the 510k application that this test has been implemented by Intertek or TUV lab already. So the data from lab testing report can be use as evidence rather than we do it by ourselves. |
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