Which three measures are typically part of the test approach in the medical domain that are not always applicable in other domains?

In the medical domain, the approach to testing is heavily influenced by the need for safety, compliance, and regulatory standards. The emphasis on a high level of documentation is crucial because it provides a clear and traceable record of every phase of the testing process. This documentation not only ensures compliance with stringent regulations imposed by health authorities, but it also plays a vital role in demonstrating the effectiveness and safety of medical products or software.

The documentation serves multiple purposes: it aids in risk management, facilitates peer reviews, and provides necessary information for investigations or audits. Given the potential impact on patient safety, thorough documentation is particularly critical in medical testing, making it a distinctive aspect compared to other industries where the same level of documentation may not be as rigorously required.

In contrast, while FMEA sessions, traceability to requirements, and test case execution are valuable in many testing contexts, they may not be emphasized as strongly or mandated in other domains outside of medical applications. This difference highlights the unique testing requirements inherent in medical devices and software, where oversight is paramount.