IEC 62304 Medical Device Certification Presentation

This presentation describes the high-level requirements for IEC 62304 software certification for medical devices.

See Verocel guidance for the following IEC 62304 aspects:

Understanding the software life cycle for medical devices

The software safety assessment process as it relates to software

Identifying software risks (an example of a real-time operating system is used

Use of Software of Unknown Provenance (SOUP)

Activities in risk assessment

Activities to ensure software meets the required assurance level for medical devices

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