Design controls: from user need to objective evidence
How user needs, requirements, design outputs, risk controls, verification and validation form a coherent evidence chain.
Verification engineers
Plans, methods, independence, acceptance criteria and objective evidence.
Articles
Related practical guidance
IEC 62304 and the medical-device software lifecycle
A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.
Verification and validation: what is the difference?
A clear explanation of verification, validation and how both connect to user needs, design inputs and objective evidence.
Primary functions, essential performance and safety-related requirements
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.
Building an audit-ready design history file
What makes development evidence coherent, reviewable and defensible before an audit or submission.