Electronics engineers
Hardware development, safety, risk controls, design evidence, verification and controlled manufacture.
Engineering practice in the context of safety, risk, verification and regulatory evidence.
Downloadable field guides
Hardware development, safety, risk controls, design evidence, verification and controlled manufacture.
Articles
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.
Does treatment naturally progress from infusion to injection and finally to a tablet—or can digitally supported subcutaneous delivery be the better destination?
A practical interpretation of Essential Performance for electronically driven injection systems, and what engineers should specify, trace and verify.
An end-to-end view of medical-device development, from intended purpose and user needs through verification, validation, transfer and maintenance.
Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.