Cybersecurity Risk Management for Medical Devices

This two-day course equips participants with essential knowledge and practical tools to effectively conduct Cybersecurity Risk Management in compliance with:

• The EU Medical Device Regulation (MDR)
• MDCG 2019-16
• IEC 81001-5-1:2021
• IEC TR 60601-4-5:2021

The course also integrates relevant elements from emerging and future harmonized standards.

Through a combination of real-world examples and interactive group work, participants will gain in-depth understanding of:

• Threat modeling techniques
• Cyber risk assessment strategies
• Secure design principles
• Regulatory and documentation requirements

Day 1

• Introduction to Cybersecurity Risk Management
• IT security basics and definitions
• Legal requirements and guidelines for medical devices security risk management
• Best practice approach
• A Notified Body’s point of view

Day 2

• Security Management
• Security by design
• Threat Modelling with respect to Medical Devices
• Update Management
• Hands-on workshop
  • Data flow diagrams
  • STRIDE
  • Post-Market security risk management

• Quality Assurance, Regulatory Affairs
• Risk Managers, Risk Management Specialists,
• Software Engineers
• Software/Hardware Engineers
• Verification and Validation Specialists
• Product Designers
• Engineers and Service Providers to manufacturers

Participants are strongly recommended to have prior knowledge of:

• Medical device development or regulation, and
• Quality Management Systems (QMS), such as ISO 13485

This foundational understanding will help participants fully benefit from the course content and group exercises.

• Best-practice approaches to Cybersecurity Risk Management under the Medical Device Regulation (MDR)
• A clear understanding of how Cybersecurity Risk Management integrates with traditional Safety Risk Management processes
• How to identify relevant assets, threats, vulnerabilities, and define appropriate mitigation measures
• Techniques to quantify security risks both before and after mitigation
• Insights into modern software tools that support threat modeling for medical devices
• Guidance on how to conduct Cybersecurity Post-Market Assessments, including surveillance and updates

• Upon successful completion of the full training, learners are eligible to take an online examination
• The exam consists of multiple-choice questions
• Total Marks: 50
• Passing Score: 70%

Participants who pass the examination will receive a Certificate of Completion, demonstrating their competence in Cybersecurity Risk Management for Medical Devices under MDR and related standards.

1. When can I get the certificate?
Certification for the Cybersecurity Risk Management Training for Medical Devices will be issued within 14 working days from the date of training completion.

2. When can I get the training material and invite?
One day before the commencement of the training program.

3. How do I pay the fees for training and examination?
Online mode

4. What are the benefits of the Cybersecurity Risk Management Training for Medical Devices?
Network Opportunities: Interact with industry peers to share insights and best practices.
Comprehensive Coverage: Obtain a holistic view of Cybersecurity risk management and threat modelling with respect to Medical Devices
Practical Knowledge: Receive actionable guidance directly applicable to real-world medical device manufacturing scenarios.
Career Development: Enhance professional credentials and marketability in the medical device industry.

5. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.