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Date of this Version

10-7-2019

Document Type

Book Chapters

Summary

  • Animal models can support and develop medical product development during the nonclinical phase.

  • Well-designed animal models can address regulatory safety concerns and can provide further de-risking during product validation.

  • Assessing minimum viable products and prototypes in animal models can improve quality assurance and compliance structure.

  • Developing a roadmap for product innovation strategies (regulatory, reimbursement) is essential in order to avoid unnecessary preclinical testing.

  • Involving end users in product development is critical for the success of the medical device in the market.

  • Animal studies can provide insight and value in the preparation of the regulatory submission.

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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