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 target product profile 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.

Download and use this workbook to:

  • Build a streamlined TPP for an IVD product.
  • Plan your product development strategy.
  • Create communications with regulatory authorities, investors, partners and employees.

Note:

MaRS 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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Defining your target product profile: In vitro diagnostic products

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Defining your target product profile: In vitro diagnostic workbook template

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