Medical Device–Custom IEC 81001-5-1 Training (9th Jan & 12th Jan)

Duration and time of training: 9th Jan & 12th Jan (09:00 to 13:00)

Cost: HKD 8,190 Per Person

Language: English

1.What is Cybersecurity

• Definition of Cybersecurity
• Why is cybersecurity important?
• How is security similar to safety?How does it difffer?

2.Common Cybersecurity Development Frameworks

• Secure Product Development Framework (SPDF)
• Total Product Lifecycle (TPLC)
• Secure-by-design

3.Basic Principles

• CIA Triad
• Authentication vs Authorization
• Encryption and Secure Communication
• Secure Design Principles
• Real-Life Examples

4.Main Activities of IEC 81001-5-1

• Quality management integrations with ISO 13485 and IEC 62304
• Software Configuration Management
• Secure Software Development

1. Secure software development planning
2. Secure software development environment
3. Security requirements specification
4. Security architecture view construction
5. Security labelling / end user instructions
6. Secure software testing
7. Software release
8. SBoM creation

• Secure Risk Management

1. Attack Surface and Threat Modelling
2. Cybersecurity Risk Assessment
3. How to link with existing ISO 14971 process
4. Software Bill of Materials Analysis (SBoM)

• Post-Market Maintenance

1. Secure updates
2. Software Problem Resolution / Anomalies
3. Vulnerability scanning
4. Vulnerability reporting to authorities and users