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MDR Cybersecurity Risk Management

Online, Instructor-Led Course

Course Description

This two-day course will provide you with key knowledge, to conduct efficient Cybersecurity Risk Management under the new requirements of the Medical Device Regulation (MDR) and MDCG 2019-16. 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.

Course Benefits

  • You learn the best practice approach for Cybersecurity Risk Management per MDR.
  • You get insight on the requirements of a Notified Body.
  • You will be able to identify all relevant assets, threats, vulnerabilities and mitigation measures.

Who Will Benefit?

The course is designed for various stakeholders of the Security Risk Management process within a medical device company:

  • Medical Device Software / Firmware Developer, Requirements Engineers, Product Designers, Software Testers
  • Quality Officer, Process Owners
  • Regulatory Affairs Officer, Risk Management Specialists, Validation Specialists
  • Managers

Max. course size: 30

Learning Objectives

  • To efficiently conduct & document a Security Risk Assessment per MDR and MDCG 2019-16
  • To design a Security Risk Management process
  • To make devices more secure with the given resources

Course Agenda

Day 1

  • Introduction into Cybersecurity Risk Management
  • IT security basics and definitions
  • Legal requirements and guidelines for medical devices
  • Security risk management process
  • Best practice for Risk Modeling
  • A Notified Body's point of view
  • Secure by Design

Day 2

  • Hands on Workshop

Methodology

Virtual Classroom with an online exam.

Learning Assessments

Online Examination

Duration

2 Days

Timing

9:00 AM – 05:00 PM

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