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 Electronics Engineers
A practical guide to developing robust electronics within a controlled medical-device lifecycle—from architecture and component selection to verification, transfer and post-market support.
What you will learn
A practical route through the lifecycle
- How electronics activities connect to the regulated lifecycle
- How to turn risk controls into verifiable hardware requirements
- What evidence supports design reviews, verification and transfer
Inside the guide
Key areas covered
- Lifecycle overview and engineering evidence
- Requirements, architecture and traceability
- Risk management for electronics
- Detailed design, EMC and electrical safety
- Prototypes, verification and design maturity
- Supplier controls and controlled manufacture
Connected knowledge