IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 4: general requirements (quality system, risk management, safety classification, legacy software) – IEC 62304:2015 Medical Device Software Lifecycle Processes

IEC 62304:2015 Medical Device Software Lifecycle Processes 4.4.4: 4.4.4 Gap closure activities

The manufacturer draws up and carries out a plan to produce the deliverables found to be missing, relying on objective evidence where it exists instead of redoing the activities of 5.2, 5.3, 5.7 and clause 7. The plan covers applying the clause 9 problem resolution process to problems found in the legacy software and its deliverables, and changes to the legacy software are made through the clause 6 maintenance process.

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