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Engineering and manufacturing industries

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ISO 9001 and regulatory compliance in the medical device industry

Article Abstract:

Issues concerning the implementation of medical device industry standards and requirements which ensure the safety of users and patients through quality control.

Author: Tsiakals, Joe
Publisher: American Society for Quality Control, Inc.
Publication Name: Quality Progress
Subject: Engineering and manufacturing industries
ISSN: 0033-524X
Year: 2001
Analysis, Laws, regulations and rules, Standardization, ISO 9001 (Standard)

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FDA announces program to strengthen medical devices safety

Article Abstract:

Highlights of Food and Drug Administration's Center for Devices and Radiological Health Postmarket Transformation Initiative program are presented.

Publisher: American Society for Quality Control, Inc.
Publication Name: Quality Progress
Subject: Engineering and manufacturing industries
ISSN: 0033-524X
Year: 2006
United States, Services introduction, New Products/Services, Company service introduction, Service introduction, Product safety, United States. Food and Drug Administration

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Will ISO 9001 still apply for the medical device industry?

Article Abstract:

The medical device industry and its use of ISO 9001 is examined.

Author: Tsiakals, Joe
Publisher: American Society for Quality Control, Inc.
Publication Name: Quality Progress
Subject: Engineering and manufacturing industries
ISSN: 0033-524X
Year: 2000

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Subjects list: Standards, Medical equipment and supplies industry, Medical equipment industry
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