What's the difference between a Performance Evaluation Report and a Performance Study for an IVD?
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Veristat
“A Performance Evaluation Report (PER) assesses existing data, including literature and equivalent device data, to establish an IVD's scientific validity and performance, while a Performance Study is a study specifically designed to confirm the IVD's analytical or clinical performance for its intended purpose.”
Sourcewww.veristat.com
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- Published
- 2026-10-25
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- 2026-10-25
- ready-scan-subjects/Q131986594
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