Defining Your Target Product Profile: In Vitro Diagnostic Products
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In vitro diagnostic (IVD) products include reagents, instruments and systems intended to screen, diagnose or monitor a disease or condition. A target product profile (TPP) for an IVD is a key strategic document that summarizes features of the intended commercial product. A well-designed TPP provides a structure to ensure that a company embarks on a product development program that is efficient and yet defines a listing of all relevant medical, technical and scientific information required to reach the desired commercial outcome.
This workbook will help you create a streamlined TPP for IVD products.
The exercise focuses on these key features of an IVD:
- Intended use statement
- Summary and explanation of how the test works
- Summary of the test procedure
- Interpretation of results
- Performance characteristics
Workbooks are comprised of two parts—the workbook guide, which contains instructions, examples and activities, and the workbook template, in which you can write your responses. You can personalize the workbook template by adding your company name and logo.
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| Workbook Guide Contains instructions, examples and activities. |
Workbook Template Write your responses and keep for your company’s records. |
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