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.