Cybersecurity for Medical Devices - Understanding Regulatory Requirements and Applying Best-Practice Approaches
This course provides a comprehensive and practice oriented introduction to cybersecurity requirements for medical devices. Participants learn how to navigate the regulatory landscape in the EU, and the USA, and how to apply key international standards and guidance documents. The training explains how cybersecurity must be integrated into risk management and quality management systems across the entire product lifecycle. Practical examples illustrate how to apply the requirements using standards-based approaches and manage cybersecurity activities after market placement.
Course Outline
- Regulatory cybersecurity requirements in the EU and the USA
- MDR expectations for information security
- Key standards and frameworks (IEC 81001 5 1, AAMI TIR57, AAMI TIR97, ANSI/AAMI SW96)
- Security risk management before market placement
- Cybersecurity integration into design and development
- Post market cybersecurity activities and incident handling
- Vulnerability management and communication pathways
- Cybersecurity processes within the QMS
- Practical examples and implementation strategies
Learning Outcomes
Understand Regulatory and Normative Requirements
- Cybersecurity expectations in the EU and the USA
- MDR requirements for information security
- Relevant standards and frameworks (IEC 81001 5 1, AAMI TIR57, AAMI TIR97, ANSI/AAMI SW96, relevant FDA Guidance documents, MDCG 2019-16)
Implement Cybersecurity Before Market Placement
- Positioning cybersecurity activities within risk management and the QMS
- Overview of security risk management concepts and documentation expectations, including security risk analysis and evaluation
Manage Cybersecurity After Market Placement
- Handling cybersecurity incidents and communication pathways
- Identifying and using reliable cybersecurity information sources
- Planning and providing security patches and updates
- Maintaining cybersecurity throughout the product lifecycle
Apply Practical Methods and Concepts
- Working with key cybersecurity concepts: assets, vulnerabilities, threats, exploits
- Understanding implications for manufacturers and quality management systems
- Developing foundational cybersecurity processes within the QMS
- Analyzing practical examples and implementation strategies
Who Should Attend
- Medical device manufacturers
- Quality management representatives
- Risk managers
- Security risk managers
- Regulatory Affairs professionals
- Auditors
Why You Should Attend
This course is ideal for professionals who need a clear understanding of cybersecurity requirements for medical devices and their practical implementation. It equips participants to integrate cybersecurity into risk management and QMS processes, apply international standards, and effectively manage vulnerabilities and incidents. The training provides practical tools and real world examples to help organizations build robust cybersecurity capabilities and meet regulatory expectations.
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