Why an FMEA is not a complete product risk analysis
Understand where FMEA helps, what it misses and how to integrate it into a complete medical-device risk-management process.
Engineering field guide · Edition 1.0
Developing and Manufacturing Medical Devices for Cybersecurity Engineers and Security Architects
A lifecycle guide to engineering secure medical devices while connecting security evidence to product safety, quality and regulatory expectations.
What you will learn
A practical route through the lifecycle
- How to define security boundaries, assets and trust relationships
- How threats become controlled, verified product requirements
- How secure development extends through suppliers and post-market support
Inside the guide
Key areas covered
- Cybersecurity engineering and product boundaries
- Assets, architecture, threat modelling and risk assessment
- Security requirements and secure software practices
- Data protection, interfaces and supply-chain controls
- Security verification and penetration testing
- Incident response, vulnerability management and maintenance
Connected knowledge