Modeling and Simulation in Biomedical Engineering: Regulatory Science and Innovation for Advancing Public Health

Author:

Morrison Tina M.ORCID,Stitzel Joel D.,Levine Steve M.

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering

Reference22 articles.

1. American Society of Mechanical Engineers, Standards Development Organization. Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices. New York: ASME, 2018

2. Center for Devices and Radiological Health. Draft Guidance for Industry and Food and Drug Administration Staff, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. Center for Devices and Radiological Health. Retrieved November 22, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions.

3. Center for Devices and Radiological Health. Guidance for Industry and Food and Drug Administration Staff. Center for Devices and Radiological Health. Retrieved November 22, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/testing-and-labeling-medical-devices-safety-magnetic-resonance-mr-environment.

4. Cohen, J. FDA Commissioner Califf Says Business of Health is Booming in U.S. But Patients’ Outcomes Aren’t Improving. Retrieved November 22, 2022, from https://www.forbes.com/sites/joshuacohen/2022/05/04/fda-commissioner-califf-says-business-of-health-is-booming-in-us-but-patients-outcomes-arent-improving/?sh=3cd436bf5edc.

5. Cowey, C. L., et al. Real-world treatment outcomes in patients with metastatic Merkel cell carcinoma treated with chemotherapy in the USA. Future Oncol. 13(19):1699–1710, 2017

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