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 Risk Managers
A practical guide to building a living risk-management process that joins hazards, controls, design evidence, production and post-market learning.
What you will learn
A practical route through the lifecycle
- How to establish intended use, boundaries and risk criteria
- How complementary analyses contribute to one risk picture
- How to verify controls and maintain the file through change
Inside the guide
Key areas covered
- The risk manager's role and regulatory foundations
- Risk-management planning and hazard identification
- Sequences of events, hazardous situations and harms
- Risk estimation, evaluation and control
- Verification of implementation and effectiveness
- Production, post-market information and recurring failures
Connected knowledge