Course Description
This 2-day course will provide you with key knowledge, to conduct efficient Cybersecurity Risk Management according to Medical Device Regulation (MDR), MDCG 2019-16, IEC 81001-5-1:2021 and IEC TR 60601-4-5:2021. 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.
Course Benefits
- 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 modeling.
- You get information on how to conduct cyber security post market assessments.
This Course is Designed For:
- Risk Managers, Risk Management Specialists, Quality Officers, Regulatory Affairs Officers
- Software Engineers, Software/Hardware Requirement Engineers, Verification and Validation Specialists
- Product Designers
- Managers
Max. course size: 20
Learning Objectives
- To efficiently conduct & document a Security Risk Assessment per MDR, MDCG 2019-16, IEC 81001-5-1:2021 and IEC TR 60601-4-5:2021
- To make devices more secure with the given resources
- To design a Security Risk Management process
Course Agenda
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
Day 2
- Hands on Workshop with data flow diagrams, STRIDE, post market security risk management etc.
Course Materials
Learners must obtain a copy of the ISO standards to be referenced during the course. The standards may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
