Risk management file

The risk management file does not have to be one document: it can point to records kept elsewhere, such as design verification results. What matters is traceability from each hazard to its risk control measures and their verification.

set of records (3.16) and other documents that are produced by risk management (3.24)

ISO 14971:2019, clause 3.25

set of records and other documents, not necessarily contiguous, that are produced by a RISK MANAGEMENT PROCESS [ISO 14971:2007, 2.23]

IEC 62304:2006+AMD1:2015, clause 3.20