Augmenting a Clinical Study With Virtual Patient Models: Food and Drug Administration and Industry Collaboration1
Author:
Affiliation:
1. Medtronic plc, Mounds View, MN 55112
2. Medical Device Innovation Consortium (MDIC), St Louis Park, MN 55416
Publisher
ASME International
Subject
Biomedical Engineering,Medicine (miscellaneous)
Link
http://asmedigitalcollection.asme.org/medicaldevices/article-pdf/doi/10.1115/1.4033870/6238160/med_010_03_030947.pdf
Reference3 articles.
1. Fracture Prediction of Cardiac Lead Medical Devices Using Bayesian Networks;Reliab. Eng. Syst. Saf.,2014
2. Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials;FDA,2010
3. Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings With FDA Staff;Center for Biologics Evaluation and Research (CBER),2015
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