CSA, Part 11 and QMSR: building a coherent software assurance approach
A practical approach to shared software assurance evidence, with clear regulatory boundaries and a worked calibration-system example.
Plans, methods, independence, acceptance criteria and objective evidence.
Articles
A practical approach to shared software assurance evidence, with clear regulatory boundaries and a worked calibration-system example.
Why standards selection for an IVD must follow the complete system, its intended purpose and the consequences of an incorrect result.
Why a long standards list is not enough—and how intended purpose, harmonisation and product-specific evidence shape a defensible standards assessment.
A playful but serious reflection on AI as assistant, reviewer and decision-maker—and why fluent answers still need evidence, judgement and accountability.
AI changes the speed and economics of medical-device development, but it does not remove the need for product definition, objective evidence, competent review or manufacturer accountability.
Why outsourcing medical-device development increases the need for intelligent manufacturer oversight—and what must be controlled before an audit or submission exposes the gaps.
Why absence of commercial registration does not automatically prevent a digital health technology from being used in a clinical trial—and the questions sponsors should ask instead.
A practical interpretation of Essential Performance for electronically driven injection systems, and what engineers should specify, trace and verify.
How user needs, requirements, design outputs, risk controls, verification and validation form a coherent evidence chain.
A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.
A clear explanation of verification, validation and how both connect to user needs, design inputs and objective evidence.
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.
What makes development evidence coherent, reviewable and defensible before an audit or submission.