Draft Details

Contact name:Taimur Qasim
Review start date:Jan 29, 2021
Review end date:Mar 30, 2021
Contact email:kelly.yaremko(at)csagroup.org
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Draft Scope/Description:

This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management.

This guidance is intended to assist manufacturers and other users of the standard to:

— understand the role of international product safety and process standards in risk management;

— develop the policy for determining the criteria for risk acceptability;

— incorporate production and post-production feedback loop into risk management;

— differentiate between “information for safety” and “disclosure of residual risk”; and

— evaluate overall residual risk

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