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Proceedings Paper

Training and education of regulatory requirements to increase the effectiveness of technology introduction
Author(s): Lillian Yin
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Paper Abstract

Thank you for inviting me to discuss with you today about issues that are so pertinent to us all, the impact of governmental regulations on health care technology. Our particular workshop put emphasis on how the training and education can increase the effectiveness of technology introduction. It is a necessity to know and to understand (the regulatory processes), the scientific requirements and how to introduce medical devices into the U.S. market. Let me relate Food and Drug Administration's (FDA's) regulations by addressing the 6 Ws - why, when, what, which, who and where.

Paper Details

Date Published: 6 December 1994
PDF: 8 pages
Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); doi: 10.1117/12.195468
Show Author Affiliations
Lillian Yin, Office of Device Evaluation/FDA (United States)


Published in SPIE Proceedings Vol. 2307:
Health Care Technology Policy I: The Role of Technology in the Cost of Health Care

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