Medical device clinical trial: design, conduct, and analysis

Richard P. Chiacchierini

doi:10.1117/12.195457

6 December 1994 Medical device clinical trial: design, conduct, and analysis

Richard P. Chiacchierini

Proceedings Volume 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care; (1994) https://doi.org/10.1117/12.195457
Event: The Role of Technology in the Cost of Health Care, 1994, Arlington, VA, United States

Abstract

The collection and evaluation of sound clinical data are the basis of the approval process for many medical devices. This paper outlines those topics that a sponsor must carefully consider in an effort to provide a meaningful evaluation and interpretation of clinical data in support of medical device Premarket Approval applications (PMA).1-3

Citation Download Citation

Richard P. Chiacchierini "Medical device clinical trial: design, conduct, and analysis", Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); https://doi.org/10.1117/12.195457

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