Medical Device Single Audit Program

Friday, 27 October 2017 by

International Medical Device Regulators Forum International Coalition Pilot Program

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List of Device Recalls

Friday, 27 October 2017 by

Oct 27, 2017: The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Use the yearly lists to find information about Class I medical device recalls and some Class II and III

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Advisories and Warnings

Friday, 27 October 2017 by

Health Canada provides timely information on issues that concern the health of Canadians. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. readmore..http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index-eng.php

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I. Background The  International Medical Device Regulators Forum (IMDRF) recognizes the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices.  The IMDRF, at its inaugural meeting in Singapore in 2012, identified a Work Group to develop specific documents for advancing the concept of the

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