Embedded software engineers
A practical software lifecycle guide spanning architecture, implementation, verification, release and maintenance.
Guide details →1 PDF · 23 August 2026
Software engineers
Embedded, application, cloud and SaMD lifecycle expectations made practical.
Downloadable field guides
Guidance written for your role
Cybersecurity engineers
Security architecture, threat modelling, secure development, verification and supported-lifetime governance.
Guide details →1 PDF · 23 August 2026
Articles
Related practical guidance
The practical guide to developing a medical device
An end-to-end view of medical-device development, from intended purpose and user needs through verification, validation, transfer and maintenance.
Why an FMEA is not a complete product risk analysis
Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.
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.
Medical-device cybersecurity: an integrated lifecycle approach
How to integrate cybersecurity governance and evidence across the complete medical-device lifecycle.
Primary functions, essential performance and safety-related requirements
A practical framework for distinguishing device functions, essential performance, safety-related requirements and supporting quality attributes.