Latest posts
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Structuring Test Cases for Medical Software Projects
Good test cases do more than record whether software passed or failed during testing. For medical software teams, well-structured test cases help create: For smaller SaMD teams especially, practical and maintainable test case structures are often more valuable than overly complex enterprise testing systems. What Is a Test Case? A test case is a documented…
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What Is a Software Verification Plan?
For many teams building Software as a Medical Device (SaMD), one of the first challenges is figuring out how to organise software verification activities in a clear and manageable way. That’s where your Software Verification plan comes in. A Software Verification Plan (SVP) is commonly used to define: For small teams, an SVP can act…
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Software Verification Documentation for SaMD: Why Good Templates Matter
What Are Document Templates? Document templates are pre-structured formats that facilitate the creation of various documents without starting from scratch. They save time and ensure consistency across documents, which is particularly important in regulated industries like the medical sector. Importance of Document Templates in the Medical Device Industry Software as a Medical Device (SaMD) companies…
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Why Structured Documentation Helps Small SaMD Teams Move Faster
For many small Software as a Medical Device (SaMD) teams, documentation can quickly become one of the most time-consuming parts of the development process. Not because the work itself is difficult — but because teams are often trying to create: at the same time they are building the software product itself. Well-designed documentation templates can…