Post-production

ISO 14971 requires a system to collect and review information from this phase and to feed it back into the risk management file. In practice this links complaints, service data and post-market surveillance to the risk analysis.

part of the life cycle (3.8) of the medical device (3.10) after the design has been completed and the medical device (3.10) has been manufactured EXAMPLE Transportation, storage, installation, product use, maintenance, repair, product changes, decommissioning and disposal.

ISO 14971:2019, clause 3.12