We would like to explicitly point out that in this seminar we are teaching the regulatory requirements and not the concrete technical implementation of IT Security.
This two-day compact seminar on IT security of medical devices pursues the learning objectives:
Time | Topic focus |
9:00 AM | Welcome, expectations, introduction |
9:20 AM | Introduction: status quo, definitions of terms, protection goals |
9:50 AM | Regulatory requirements for IT security |
10:45 AM | Break |
11:00 AM | Derivation of the most important activities from the regulatory requirements |
11:45 AM | EU-DSGVO and application to IT security of products |
12:15 PM | Lunch |
1:15 PM | General requirements for quality and risk management |
2:00 PM | Planning |
2:15 PM | Requirements engineering |
3:00 PM | Break |
3:15 PM | Architecture, Defense-in-depth, Threat Modeling |
5:00 PM | Summary, recap, Q&A session |
5:15 PM | End day 1 |
Time | Topic focus |
9:00 AM | Greeting and repetition |
9:20 AM | Other activities in the product life cycle: design, implementation, verification, release, maintenance |
10:45 AM | Break |
11:00 AM | Risk management for IT security |
12:15 AM | Lunch |
1:15 PM | Post-market activities |
2:15 PM | Technical documentation for IT security |
3:00 PM | Break |
3:15 PM | Integration of IT security activities into your own process landscape |
4:00 PM | IEC 81001-5-1 and IEC 60601-4-5 and their application |
4:30 PM | IT security in own company and as operator, EU-DSGVO, ISO 27001 |
5:00 PM | Summary, recap, Q&A session |
5:15 PM | End of the seminar |
This seminar on IT security for medical devices is aimed in particular at the following persons: