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 4.2: 4.2 Risk management

The manufacturer runs a risk management process that meets ISO 14971; clause 7 on software risk management explains how that process deals with software.

Maintained by Gerard BlokdykControl text last updated 21 May 2026

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

4.1 4.1 Quality management system
4.3 4.3 Software safety classification
4.4.1 4.4.1 General
4.4.2 4.4.2 Risk management activities
4.4.3 4.4.3 Gap analysis
4.4.4 4.4.4 Gap closure activities
4.4.5 4.4.5 Rationale for use of legacy software

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MCP endpoint All IEC 62304:2015 Medical Device Software Lifecycle Processes controls