A target product profile (TPP) for a medical device is a key strategic document that summarizes the value proposition of the intended commercial product and assists in the development of a regulatory strategy. A well-designed TPP provides a structure to ensure that a company embarks on a product development program that is efficient and defines all relevant medical, technical and scientific information required to reach the desired commercial outcome.

Medical devices include instruments, apparatus or implants intended for use in the cure, mitigation, diagnosis, treatment or prevention of disease. (For medical devices related to in vitro diagnostic [IVD] products, see the TPP workbook and template designed for IVDs.)

Download and use this workbook to:

  • Build a streamlined target product profile for a medical device.
  • Plan your product development strategy.
  • Create communications with regulatory authorities, investors, partners and employees.

Note:

MaRS workbooks are comprised of two elements—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: Medical device product

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Defining your target product profile: Medical device products workbook template

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