Best Practice Medical Device Regulation (MDR) Cybersecurity Risk Management

Instructor-led Training2 DaysIntermediate
  • To efficiently conduct and document a Security Risk Assessment per MDR, MDCG 2019-16. IEC 81001-5-1:2021 and IEC TR 60601-4-5:2021
  • To understand how to make medical devices safer with given resources
  • To be able to confidently develop a process for security 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.

Price (excl. TAX)
$ 1,750.00

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