Seminar „IT Security of Medical Devices“

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

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