With the rapid development of information technology, the application of software in medical devices is becoming more and more common, the role is becoming more and more important, flexible and changeable, and new technologies are emerging. However, the resulting quality problems are also increasing, medical device recall data show that the number of software-related recalls continues to increase, significantly higher than the overall level of medical devices during the same period, while software failure resulting in patient death or serious injury recalls are not uncommon, so the seriousness of software quality problems can not be ignored.
Software has no physical entities, human factors are everywhere during development and use, software testing due to time and cost constraints can not exhaust all situations, so software defects can not be avoided. At the same time, software updates are frequent and rapid, and minor updates can lead to serious consequences, as well as cumulative effects and degradation issues (i.e., a new defect occurs every time several defects are fixed), so software defects cannot be eradicated. Therefore, software defects can be regarded as one of the inherent properties of software, which is also the root cause of software quality problems.
Your software lifecycle should include the software system from concept definition to deactivation of the time period, including software:
If you need assistance with SiMD, whether it's an application for approval of a new medical device, meeting medical device cybersecurity requirements, or any of the pertinent activities related to Software in a Medical Device, feel free to contact us.
Software traceability analysis, as one of the important activities of software verification and software confirmation, refers to tracking the relationship between software requirements, software design, source code, software testing, software risk management, and analyzing the correctness, consistency, completeness, and accuracy of identified relationships.
Software requirements analysis retroactively analyzes the relationship between software requirements and product requirements, software requirements, and risk analysis.
Software design retroactively analyzes the relationship between software design and software requirements, software design, and risk control.
Software coding retrospectively analyzes the relationship between source code and software design, source code, and test cases.
Internal test retrospective analysis unit testing, integration testing, system testing test cases and software design at all levels, system testing and software requirements, system testing, and risk management relationship.
User testing retroactively analyzes the relationship between user testing and product requirements, user testing, and risk management. Software updates should also conduct software traceability analysis.