Seminar „IT Security of Medical Devices“

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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.

Time	Topic focus
09:00	Welcome, expectations, introduction
09:20	Introduction: status quo, definitions of terms, protection goals
09:50	Regulatory requirements for IT security
10:45	Break
11:00	Derivation of the most important activities from the regulatory requirements
11:45	EU-DSGVO and application to IT security of products
12:15	Lunch
13:15	General requirements for quality and risk management
14:00	Planning
14:15	Requirements engineering
15:00	Break
15:15	Architecture, Defense-in-depth, Threat Modeling
17:00	Summary, recap, Q&A session
17:15	End day 1

Time	Topic focus
09:00	Greeting and repetition
09:20	Other activities in the product life cycle: design, implementation, verification, release, maintenance
10:45	Break
11:00	Risk management for IT security
12:15	Lunch
13:15	Post-market activities
14:15	Technical documentation for IT security
15:00	Break
15:15	Integration of IT security activities into your own process landscape
16:00	IEC 81001-5-1 and IEC 60601-4-5 and their application
16:30	IT security in own company and as operator, EU-DSGVO, ISO 27001
17:00	Summary, recap, Q&A session
17:15	End of the seminar

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