Seminar „IT Security of Medical Devices“

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

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