Guides
Guides for regulated, safety-critical development.
Practical, vendor-neutral explainers on requirements traceability, regulatory frameworks, and the engineering lifecycle — written for the teams who build under audit.
RSS feed → Medical Device The Design History File (DHF) in 2026: what QMSR changed What a Design History File is, what belongs in it, and how the FDA's QMSR transition (effective February 2026) renames it to the Design and Development File under ISO 13485 — with the underlying design-control requirement unchanged. Fundamentals What is Application Lifecycle Management (ALM)? A clear introduction to Application Lifecycle Management — what ALM covers, how it differs from project or just requirements management, why traceability is its backbone, and what ALM means for regulated, safety-critical development. Automotive ISO 26262 traceability: from safety goals to verification How ISO 26262 builds functional safety into automotive development — ASILs, the safety lifecycle and V-model, and the traceability that links safety goals through requirements to verification evidence. Aerospace DO-178C requirements management and traceability, explained How DO-178C structures airborne software assurance — design assurance levels, the requirements hierarchy, bidirectional traceability, and requirements-based testing — and why trace data is the backbone of certification. Requirements How to write clear requirements with the EARS notation A practical guide to writing clear, testable requirements using EARS (Easy Approach to Requirements Syntax) — the five patterns, examples of each, and how structured requirements make verification and traceability far easier. Medical Device IEC 62304: the medical device software lifecycle, explained How IEC 62304 structures medical device software development — software safety classes A, B, and C, the lifecycle processes it requires, its link to ISO 14971 risk, and why traceability ties the whole thing together. Buyer's Guide Choosing requirements and traceability software: an evaluation guide A vendor-neutral framework for evaluating requirements and traceability tools for regulated, safety-critical work — the criteria that matter, the architectural question behind them, and the questions to ask every vendor. Compliance FDA 21 CFR Part 11: a practical guide to electronic records and signatures What 21 CFR Part 11 requires — electronic records, electronic signatures, audit trails, validation, and access controls — how the QMSR transition affects it, and what "Part 11 compliant" software really means. Cybersecurity SBOM and FDA cybersecurity: what Section 524B requires What a software bill of materials is, why FDA Section 524B now requires one for cyber devices, what a compliant SBOM contains, and how connecting it to your requirements and risk turns it from a list into a vulnerability-impact tool. Traceability What is a requirements traceability matrix (RTM)? A plain-English guide to the requirements traceability matrix — what it is, what belongs in it, the forward and backward links that make it work, and why it matters for regulated, safety-critical development.