This two-day compact seminar on IT security of medical devices pursues the learning objectives:
Time | Topic focus |
09:00 | Welcome, expectations, introduction |
09:20 | Introduction: status quo, definitions of terms, protection goals |
09:50 | Regulatory requirements for IT security |
10:45 | Break |
11:00 | Derivation of the most important activities from the regulatory requirements |
11:45 | EU-DSGVO and application to IT security of products |
12:15 | Lunch |
13:15 | General requirements for quality and risk management |
14:00 | Planning |
14:15 | Requirements engineering |
15:00 | Break |
15:15 | Architecture, Defense-in-depth, Threat Modeling |
17:00 | Summary, recap, Q&A session |
17:15 | End day 1 |
Time | Topic focus |
09:00 | Greeting and repetition |
09:20 | Other activities in the product life cycle: design, implementation, verification, release, maintenance |
10:45 | Break |
11:00 | Risk management for IT security |
12:15 | Lunch |
13:15 | Post-market activities |
14:15 | Technical documentation for IT security |
15:00 | Break |
15:15 | Integration of IT security activities into your own process landscape |
16:00 | IEC 81001-5-1 and IEC 60601-4-5 and their application |
16:30 | IT security in own company and as operator, EU-DSGVO, ISO 27001 |
17:00 | Summary, recap, Q&A session |
17:15 | End of the seminar |
This seminar on IT security for medical devices is aimed in particular at the following persons: