The plan for risk management activities on the device: scope, responsibilities, criteria for risk acceptability, verification activities and how post-market information will be used.
Plan Work product in the Medical electronics and medical device chips lifecycle
It sets the rules for judging risk before risks are judged. Decisions made case by case cannot evaluate residual risk consistently, and auditors question whether the process was followed.
The full lifecycle detail, with its charts, flows, tables and every section, is for registered members. Registration is free and takes a minute. You come back to this page afterwards.