Protection and Security in Focus
Two-day practical course
Do you want your products to be not only compliant with standards, but also secure and robust against modern threats? Do you want to ensure you are using well-founded and widely accepted methods to analyse potential vulnerabilities in medical devices?
In this seminar, you will learn how to set up your risk management processes to reflect the fundamental concepts and best practices of cybersecurity risk management for medical devices. Whether your products are networked or stand-alone, we will show you – through many illustrative examples and exercises – how to conduct a threat analysis, efficiently and effectively integrate resulting security requirements into your development processes, and manage identified vulnerabilities throughout the product life cycle.
- Content
- Relevant standards and guidelines in Europe and the USA
- Fundamental concepts for designing secure medical devices
- Linking the ISO 14971 risk management process with cybersecurity risk management
- Threat analysis and risk assessment across the entire product life cycle
- Practical exercises in cybersecurity risk analysis
- Your Benefits
- With the knowledge gained in the seminar, you will be able to link cybersecurity risk management processes with risk management under ISO 14971.
- You will learn how to design an effective cybersecurity risk management system to control risks and leverage opportunities.
- You will receive a clear, comprehensible overview of regulatory requirements for the security of medical devices.
- You can use the interactive exercises to address your specific questions and exchange experiences with other participants.
- You will receive practice-oriented solutions and ideas for your company.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Medical device manufacturers
- Risk Managers and members of risk management teams
- Members of development teams
- Regulatory Affairs Managers
- Quality Management representatives
- Auditors
