Seminar „IT Security of Medical Devices“

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Targets

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:

  • 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 methods in 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.

Content

Day 1

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

Day 2

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

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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