Focus on Protection and Security
Do you want to design your products not only tocomply withstandards, but also to be secure and resilient against modern threats? Do you want to ensure that you are using well-founded and recognized methods to analyze potential vulnerabilities in medical devices?
In this training, learn how to set up your risk management processes to implement fundamental concepts and best practices in the field of cybersecurity risk management for medical devices. Whether your products are networked or standalone, we’ll use numerous illustrative examples and exercises to show you how to conduct a threat analysis, efficiently and effectively integrate the resulting security requirements into your development processes, and address identified vulnerabilities throughout the entire product lifecycle.
- Content
- Relevant standards and guidelines in Europe and the United States
- Fundamental concepts for the design of safe medical devices
- Integrating the risk management process according to ISO 14971 with cybersecurity risk management
- Threat analysis and risk assessment throughout the product lifecycle
- Practical exercises in cybersecurity risk analysis
- Your Benefits
- Learn how to build, maintain, and optimize a process-oriented QMS efficiently in accordance with ISO 13485.
- Implement regulatory requirements effectively and enhance your company’s compliance and performance.
- Benefit from practical examples showing how to streamline processes without compromising quality.
- As a QMR, gain valuable insights to strengthen your interface role between management, staff, and regulatory authorities.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices
- Suppliers, subcontractors, and service providers
- Personnel from Quality Assurance (QA) and Quality Management (QM)
- Top management
- (Future) Quality Management Representatives (QMRs)
- Auditors
- Regulatory or authority personnel
