Houssam·Jul 2180% Automated, 20% Validated: How We Generate IEC 62304 Architecture Docs with Claude and a Lead…A practitioner’s account of building a Python pipeline that turns a YAML manifest into a regulatory-grade Software System Architecture…
Elton Kuzniewski·Feb 2IEC 62304 Isn’t Anti-Agile — Your Implementation Might BeIf you’re building medical device software and scaling delivery with SAFe, you’ve probably felt the tension:
Subrata Sarkar·Dec 7, 2025Fail-Fast Error Handling and Deterministic Fault Injection in Embedded CA Disciplined Pattern for Safety-Critical Firmware
Meindert Niemeijer·Nov 30, 2023RoboClerk Integrates AI to Review and Create SaMD DocumentationIf you’re involved in software development within the medical device sector, you’re intimately familiar with a common bottleneck: the…
Sequenex·Sep 28, 2023Medical Tech Software Safety and IEC 62304Today in our International Standards series, we take a look at IEC 62304. This standard defines an agreed upon framework for developing…
Matrix One·Jul 5, 2023Agile Compliance — The 9 most important terms of IEC 62304 and what they mean for Agile Developersoin us as we jump into season 2 on the most important terms of IEC 62304 and their impact on agile development…
Matrix One·Jan 24, 2023Agile Compliance - Agile Software Development explained for RAQAThe agile development process applied by practically all software development teams across all industries, as a primer for QA/RA teams.
