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 Systems Engineers
A systems-level guide to turning intended purpose into a controlled, testable and manufacturable medical device.
What you will learn
A practical route through the lifecycle
- How to establish a defensible product boundary and architecture
- How requirements, risks and interfaces form one evidence system
- How systems engineering supports validation, transfer and lifecycle change
Inside the guide
Key areas covered
- The systems-engineering role
- Intended purpose and regulatory foundations
- Architecture, requirements and interfaces
- Safety, usability, security and interoperability
- Integration, verification and system validation
- Transfer, post-market learning and recurring failures
Connected knowledge