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.