Software maintenance

Each type of maintenance is a change to a released product, so it goes through change control and, where needed, a new regulatory assessment. IEC 82304-1 requires a maintenance plan and information to users about updates.

modification of HEALTH SOFTWARE PRODUCT after release for INTENDED USE, for one or more of the following reasons: a) corrective, as fixing faults; b) adaptive, as adapting to new hard- or software platform; c) perfective, as implementing new requirements; d) preventive, as making the product more maintainable Note 1 to entry: See also ISO/IEC 14764:2006.

IEC 82304-1:2016, clause 3.21