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.
Engineering field guide · Edition 1.0
Developing and Manufacturing Medical Devices for Embedded Software Engineers
Connect embedded software engineering with system risk, IEC 62304 lifecycle evidence, cybersecurity, configuration control and product validation.
What you will learn
A practical route through the lifecycle
- How software work products fit the wider device lifecycle
- How classification and risk influence lifecycle rigour
- How to plan traceable verification, release and maintenance evidence
Inside the guide
Key areas covered
- Lifecycle contributions and software planning
- Intended use, classification and architecture
- Requirements and detailed software design
- Implementation, integration and verification
- Cybersecurity and software risk controls
- Release, maintenance and problem resolution
Connected knowledge