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Designing a Preclinical Program for Your Medical Device

Updated: Dec 28, 2021

The prospect of designing a preclinical program can be daunting, particularly if there is no precedent for the data needed and relevant models.

Here are some items to consider when getting started:

1. What is the question you are trying to solve – safety and/or efficacy? This will dictate your models and the study duration.

2. What are the FDA requirements – are there guidance documents already published for your device type? Partner with FDA early to ensure you will obtain the data they will want to see.

3. Is there precedence in the literature for certain models? Leverage previous research if possible.

4. Choose a CRO with experience in the field – they can guide you on the above and set you on the road to success with preclinical data to support early feasibility studies.

We’re here to help!

Our CRO has extensive experience in the preclinical field and can partner with you to plan, develop and execute your studies. Go to to learn more about our services.

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