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DS/ISO/TR 24971:2013
Medical devices - Guidance on the application of ISO 14971
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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Danish Standards [ds]
