https://bitcrushtesting.com/en/tags/iec-62304/Recent content in IEC-62304 on BitcrushHugoen-USFri, 12 Sep 2025 19:00:00 +0000https://bitcrushtesting.com/en/blog/software-requirements-for-safety-applications/Fri, 12 Sep 2025 19:00:00 +0000https://bitcrushtesting.com/en/blog/software-requirements-for-safety-applications/<p>When developing safety-critical systems, software requirements are not just an item on a checklist — they are the foundation for everything that follows. From design and verification through certification to maintenance: the clarity and correctness of your requirements can determine whether your product succeeds or fails, especially when lives depend on how the system behaves.</p>https://bitcrushtesting.com/en/blog/iec62304_testing/Fri, 12 Sep 2025 19:00:00 +0000https://bitcrushtesting.com/en/blog/iec62304_testing/<p>When developing software for medical devices, safety is not merely a goal — it is a legal and ethical obligation. Among the many standards that govern this domain, IEC 62304 stands out as the central international standard for the lifecycle of medical device software. A fundamental part of IEC 62304 conformance is systematic testing for functional safety. But what does that mean in practice?</p>