Electronics engineers
Hardware development, safety, risk controls, design evidence, verification and controlled manufacture.
Product definition, architecture, interfaces, risk controls and end-to-end traceability.
Downloadable field guides
Hardware development, safety, risk controls, design evidence, verification and controlled manufacture.
A practical software lifecycle guide spanning architecture, implementation, verification, release and maintenance.
Product definition, architecture, interfaces, requirements, risk and traceability across the complete lifecycle.
ISO 14971-centred risk management connected to engineering decisions, evidence and lifecycle governance.
Security architecture, threat modelling, secure development, verification and supported-lifetime governance.
Articles
An end-to-end view of medical-device development, from intended purpose and user needs through verification, validation, transfer and maintenance.
How user needs, requirements, design outputs, risk controls, verification and validation form a coherent evidence chain.
Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.
A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.
How to integrate cybersecurity governance and evidence across the complete medical-device lifecycle.
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.