In this seminar, manufacturers and operators of medical devices learn about and implement the regulatory requirements for IT security and data protection. This seminar also addresses the EU General Data Protection Regulation (GDPR).
goalsThis two-day compact seminar on the 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 areas of application (e.g. EU / FDA / international, industry-specific / non-specific, manufacturer / operator). - EU General Data Protection Regulation (EU-GDPR)
You can bring the requirements of the EU General Data Protection Regulation into 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 deal with terms such as threat, vulnerability, asset. - IT security-related system & software requirements
You will receive an overview of the specific IT security requirements (software / system requirements) that result from the application of the relevant standards and laws. - security analysis
You can apply methods (e.g. threat modelling, threat analysis and risk assessment) and thus systematically analyze and minimize IT security risks. - security testing
You know important test strategies for IT security, eg penetration testing or fuzz tests - Development and post-market processes
You will understand how the continuous guarantee of IT security can be embedded in the development process and in post-market surveillance and which data sources and roles are available for this.
KONTAKT:
Online Seminar
