Seminar „IT Security of Medical Devices“

Kein Seminartermin
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This two-day compact seminar on IT security of medical devices pursues the learning objectives:

  • Regulatory requirements
    You know the regulatory requirements for IT security and can classify them according to application areas (e.g. EU / FDA / international, industry-specific / non-specific, manufacturer / operator).
  • EU Basic Data Protection Regulation (EU-DSGVO)
    You can put the requirements of the EU General Data Protection Regulation in the context of the requirements for IT security of the products.
  • Basics and terms
    You know the protection goals of IT security in the context of medical devices and can confidently handle terms, e.g. threat, vulnerability, asset.
  • IT Security-Related System & Software Requirements
    You will receive an overview of the specific IT security requirements (software / system requirements) resulting from the application of the relevant standards and laws.
  • Security Analysis
    You can apply methods (e.g. Threat Modeling, Threat Analysis and Risk Assessment) to systematically analyze and minimize IT security risks.
  • Security Testing
    You know important test strategies for IT security, e.g. penetration testing or fuzz tests
  • Development and Post-Market Processes
    You understand how continuous assurance of IT security can be embedded into the development process and post-market surveillance, and what data sources and roles are available for this.


Day 1

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

Day 2

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

Target group

This seminar on IT security for medical devices is aimed in particular at the following persons:

  • (Software) developer and software tester
  • Employees in IT
  • Regulatory Affairs and Quality Manager
  • Risk managers and safety officers
  • Project Manager and Product Manager


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