scope:

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