Best Practice Medical Device Regulation (MDR) Cybersecurity Risk Management

• Risk Managers, Risk Management Specialists, Quality Officers, Regulatory Affairs Officers
• Software Engineers, Software / Hardware Requirement Engineers, Verification and Validation specialist
• Product Designers
• Managers

Day 1

• Introduction into Cybersecurity Risk Management
• IT security basics and definitions
• Legal requirements and guidelines for medical device security risk management
• Best practice approach
• A Notified Body's point of view
• Hands on Workshop with data flow diagrams, STRIDE, post market security risk management etc.

Day 2

• Hands on Workshop with data flow diagrams, STRIDE, post market security risk management etc.

This two-day course will provide you with key knowledge, to conduct efficient Cyber Security Risk Management under the new requirements of the Medical Device Regulation (MDR) and MDCG 2019-16, IEC 81001-5-1:2021 and IEC TR 60601-4-5:2021. This course will also integrate relevant elements of future harmonized standards. Through examples and group work you will gain in-depth knowledge on relevant threat modelling techniques, risk assessment strategies, secure design principles and documentation needs.

• You learn the best practice approach for MDR Cybersecurity Risk Management.
• You get a thorough understanding of an effective Cybersecurity Risk Management process and its interaction with the classical Safety Risk Management process
• You will be able to identify all relevant assets, threats, vulnerabilities, and mitigation measures.
• You will be able to accurately quantify security risks prior and post mitigation
• You get background information on the relevant compulsory and voluntary guidelines international guidelines for medical device security management
• You get insight on the requirements of a Notified Body.
• You get information on computer tools supporting modern medical device threat modelling
• You get information on how to conduct cyber security post market assessments

Virtual Classroom with an online exam.

Online Examination

Please bring a copy of the MDR with you to the course. A free copy can be downloaded from the EUR-Lex European Union law website.