IEC 62304:2015 Medical Device Software Lifecycle Processes
Clause 4 - General Requirements

IEC 62304:2015 Medical Device Software Lifecycle Processes IEC62304-4.2: Risk Management

The manufacturer's risk management activities shall be performed as defined in ISO 14971. Software is considered a contributing factor to hazardous situations and must be addressed in risk management.

Other controls in Clause 4 - General Requirements

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