In our free whitepaper below, our Head of Quality Dr Dirk Hüber addresses the certain challenges and special aspects that need to be considered when undertaking risk management for software (be it Software as a Medical Device – SaMD, or Software in a Medical Device – SiMD).
Within the paper, the implications for the risk analysis, as well as for the different FMEA types are discussed – starting with Software FMEAs, continuing with an explanation of the consequences for risk analysis, before moving onto other FMEA types. This sequence has been chosen because the core focus in software risk management is on risks caused by software failures.
Dr Hüber also provides advice on security assessments, Software of Unknown Provenance (SOUP), and software updates based on general requirements stated in IEC 62304 (Software Lifecycle Management).
Before reading this whitepaper, we recommend reading two of our previous articles that explain some fundamental principles of state-of-the-art risk management according to ISO 14971 which are applied in this whitepaper:
- Risk Analysis v FMEA: How knowing the difference benefits your risk management
- How to connect failure modes and risks in a risk management file
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For more information on the full breadth of our Quality services, see here.
