Seminar „IT Security of Medical Devices“

Targets

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.

Content

Day 1

Day 2

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