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 4.4.1: 4.4.1 General

For software developed before the standard existed, instead of applying clauses 5 to 9 the manufacturer may show compliance of the legacy software through the risk management activities, gap analysis, gap closure and documented rationale set out in clauses 4.4.2 through 4.4.5.

Maintained by Gerard BlokdykControl text last updated

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

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.