Experimental Design & Risk Analysis

BioSim Innovations can provide services to address risk analysis:

  • Identify models that answer both anatomy AND physiology questions

  • Design, test and clinically evaluate devices, identify the root causes of adverse events and device malfunctions, develop iterative device designs, and navigate the regulatory process

  • Anticipate and manage medical issues that may arise during the course of clinical studies

  • Models for device design, preclinical data, human factors, training

  • Minimize patient exposure to significant and unnecessary safety risks. Provide better testing for physiological response to device

  • Characterize effect of device actuation on inflammatory response and tissue interface through markers and histology

  • Regulatory science- help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes

Work with us

Contact us today to drive your development from concept to clinical release with unparalleled innovation, speed, and experience.

Tel. 763.445.9607

 Address. 11600 96th Avenue North, Maple Grove, MN  55369

© 2020 switchback biosim innovations 

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