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Understanding Performance Evaluation Reports

The Performance Evaluation Report (PER) for in-vitro diagnostic (IVD) devices is compared to a school report card, assessing the device's performance in detecting diseases. Regulatory authorities act as teachers, ensuring that the device meets safety and performance standards. The PER evaluates the device's reliability using real-world data, similar to how a report card reflects a student's academic progress.

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Shami Christo A
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41 views1 page

Understanding Performance Evaluation Reports

The Performance Evaluation Report (PER) for in-vitro diagnostic (IVD) devices is compared to a school report card, assessing the device's performance in detecting diseases. Regulatory authorities act as teachers, ensuring that the device meets safety and performance standards. The PER evaluates the device's reliability using real-world data, similar to how a report card reflects a student's academic progress.

Uploaded by

Shami Christo A
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd

PER (Performance Evaluation Report) – A Simple Analogy

Think of a PER like a school report card for a student (in-vitro diagnostic (IVD) medical
device).

🔹 Analogy:
Imagine a student (IVD device) is given various tests to check their knowledge and skills (how
accurately the IVD device detects diseases).

 The PER is like the student's report card, showing how well they performed in exams
(analytical and clinical performance data).
 Teachers (regulatory authorities) check if the student meets the required academic
standards (IVD device meets safety and performance criteria).
 If the student is struggling in a subject, extra practice or improvements are needed
(device modifications or better testing methods).

📌 Key Point: A PER ensures that an IVD device can reliably detect or measure a medical
condition by evaluating its performance with real-world data, just like a report card evaluates a
student's academic progress. 🎓🔬

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