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