Seminar „IT Security of Medical Devices“

Kein Seminartermin
There is currently no known date for this seminar. Please try again at a later date or contact us.

Goals

This one-day compact seminar on IT security of medical devices pursues these 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 General Data Protection Regulation (EU-GDPR)
    You have an overview of the EU General Data Protection Regulation and know which requirements result from it for the development of medical devices.
  • Basics and terms
    You know the protection goals of IT security in the context of medical devices and can handle terms confidently, e.g. distinguish IT security from cybersecurity.
  • Security analysis, penetration testing
    You can apply models (e.g. Threat Modeling) and use them to systematically analyze IT security risks and create product-specific checklists. You know procedures and tools to test the IT security of medical products, such as penetration testing, reverse engineering, etc.
  • 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 appropriate for this purpose.
  • IT Security related System & Software Requirements
    You will get an overview of the concrete IT security requirements (software / system requirements) resulting from the application of the relevant standards and laws.

Agenda

TimeTopic
09:00Start of seminar
09:00Expectations, introduction
09:20Introduction: status quo, definitions of terms, protection goals
09:50Regulatory requirements for IT security
10:45Break
11:00EU-GDPR, difference between IT security officer and data protection officer
12:00Summary, review, Q&A
12:15Lunch break
13:15Modeling (incl. exercise), checklists
14:00Vulnerability analysis procedures (incl. penetration testing), vulnerability databases
15:00Break
15:15IT Security related Software Requirements, UL 2900, ISO 15408
16:00IT security in the development process, management of vulnerabilities
16:30Post Market IT Security, Interaction with risk management
17:00Summary, review, Q&A
17:15End of seminar

Target groups

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

  • (Software) Developers and Software Engineers
  • Employees in IT
  • Regulatory Affairs and Quality Manager
  • Risk managers and safety officers
  • Project Manager and Product Manager