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Regulatory Affairs and Product Integrity

 

作者: V.,  

 

期刊: Journal of Clinical Engineering  （OVID Available online 1979）
卷期: Volume 4, issue 4  

页码: 353-356

 

ISSN:0363-8855

 

年代: 1979

 

出版商: OVID

 

关键词: Regulations, Federal;Medical Device Amendments;Device Regulation;Product Integrity

 

数据来源: OVID

 

摘要:

This review analyzes the regulations and control resulting from theMedical Device Amendments of 1976, and their effect onproduct integrity.There is a discussion on claims, safety considerations, recalls, cost factors, and the advantages and disadvantages of increasing governmental regulation of medical devices. A glossary of regulatory terms is included.

 

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