EXECUTIVE SUMMARYISO 14971
is an international risk
management standard for The purpose of this standard is to
help manufacturers to establish ISO 14971 was first published in
2000. This second edition was In addition, it became clear that
product safety standards cannot |
SCOPE OF STANDARDISO 14971 applies to all medical
device manufacturers and all However, this standard does not
apply to clinical decision making. |
REGULATORY ENVIRONMENTISO 14971 is widely recognized as
the official standard for medical Medical device risk management is now mandatory in most |
CERTIFICATIONISO 14971 does not expect medical
device manufacturers to However, regulators may require
certification and your customers While this standard does not expect
you to become certified, |
STEP-BY-STEP OVERVIEWISO 14971 describes a risk
management process 3. Establish your risk management
framework. The following flowchart summarizes
this material in diagrammatic form. |
MORE ISO 14971 PAGES Overview of Medical Device Risk Management Standard Plain English Medical Device Risk Management Definitions ISO 14971 Medical Device Standard Translated into Plain English |
OTHER RELATED LIBRARIES |
Praxiom Research Group Limited help@praxiom.com 780-461-4514 |
|||
Updated on May 16, 2016. First published on February 28, 2011. |
|||
Legal Restrictions on the Use of this Page Copyright © 2011 - 2016 by Praxiom Research Group Limited. All Rights Reserved. |