Subclause 3.1 requires the manufact

Subclause 3.1 requires the manufacturer to establish a risk management process as part of the design of amedical device. This is required so that the manufacturer can systematically ensure that the required elementsare in the process. Risk analysis, risk evaluation and risk control are commonly recognised as essential partsof risk management. In addition to these elements, this International Standard emphasises that the riskmanagement process does not end with the design and production (including, as relevant, sterilization,packaging, and labelling) of a medical device, but continues on into the post-production phase. Therefore, thegathering of post-production information was identified as a required part of the risk management process.Furthermore, it was felt that when a manufacturer employs a quality management system, the riskmanagement process should be fully integrated into that quality management system.