Paper
6 December 1994 Training and education of regulatory requirements to increase the effectiveness of technology introduction
Lillian Yin
Author Affiliations +
Proceedings Volume 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care; (1994) https://doi.org/10.1117/12.195468
Event: The Role of Technology in the Cost of Health Care, 1994, Arlington, VA, United States
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.
© (1994) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE). Downloading of the abstract is permitted for personal use only.
Lillian Yin "Training and education of regulatory requirements to increase the effectiveness of technology introduction", Proc. SPIE 2307, Health Care Technology Policy I: The Role of Technology in the Cost of Health Care, (6 December 1994); https://doi.org/10.1117/12.195468
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KEYWORDS
Medical devices

Medicine

Safety

Control systems

Manufacturing

Medical research

Medical device development

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