Latest posts
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Requirements Traceability for Small SaMD Teams
Requirements traceability is one of those concepts that almost everyone agrees is important, but far fewer teams find easy to implement in practice. At the start of a project, traceability often feels unnecessary. There may only be a handful of requirements, a small number of tests, and a team that communicates frequently. It is usually…
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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…
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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…