CSA, Part 11 and QMSR: building a coherent software assurance approach
A practical approach to shared software assurance evidence, with clear regulatory boundaries and a worked calibration-system example.
Engineering field guide · Edition 1.0
Developing and Manufacturing Medical Devices for Product Managers and Product Owners
A practical guide to leading medical-device product development while preserving user value, evidence, risk control and commercial clarity.
What you will learn
A practical route through the lifecycle
- How product leadership differs in a regulated environment
- How to frame intended purpose, value and acceptance criteria
- How to make portfolio and launch decisions using controlled evidence
Inside the guide
Key areas covered
- Product leadership in a regulated environment
- Intended purpose and medical-device foundations
- Product strategy and target profile
- Stakeholders, requirements and traceability
- Risk management, design reviews and evidence readiness
- Launch, post-market learning and end of life
Connected knowledge