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What Is Involved in a Regulatory Trial...
Journal article

What Is Involved in a Regulatory Trial Investigating a New Medical Device?

Abstract

Regulatory trials allow for the clinical evaluation of new drugs and medical devices, determining whether or not they can be safely and effectively used in patient care. The outcome of these trials may result in new and better ways of preventing, diagnosing, and treating illness. However, conducting a regulatory trial to evaluate a new medical device is a complex and time-intensive process involving many parties. This paper will provide an …

Authors

McKay PJ; Resendes S; Schemitsch E; Bhandari M

Journal

Journal of Long-Term Effects of Medical Implants, Vol. 17, No. 2, pp. 165–171

Publisher

Begell House

Publication Date

2007

DOI

10.1615/jlongtermeffmedimplants.v17.i2.90

ISSN

1050-6934