Safety Risk Management for Medical Devices: Aligning with ISO 14971:2019 Training by Tonex
This comprehensive training course, “Safety Risk Management for Medical Devices: Aligning with ISO 14971:2019,” offered by Tonex, is designed to equip professionals in the medical device industry with the essential knowledge and skills needed to navigate the complex landscape of safety risk management.
Participants will gain a deep understanding of ISO 14971:2019 and learn how to effectively apply its principles to ensure the safety and compliance of medical devices throughout their lifecycle.
This advanced training course, “Safety Risk Management for Medical Devices: Aligning with ISO 14971:2019,” offered by Tonex, delves into the intricacies of managing safety risks in the dynamic field of medical devices.
Participants will gain a profound understanding of ISO 14971:2019, the benchmark standard for risk management in the industry. This program empowers professionals with the knowledge to identify, assess, and control risks throughout the lifecycle of medical devices, ensuring compliance and patient safety.
Through a comprehensive curriculum, attendees will master the integration of ISO 14971:2019 principles into their organizations, enhancing their capabilities in navigating regulatory landscapes and optimizing product development processes.
Course Objectives:
- To understand the essential safety risk management methodologies for medical devices compliant with ISO 14971:2019.
- To learn state-of-the-art safety risk assessment practices specific to the MedTech sector.
- To gain insights into the latest industry best practices and international standards.
- To develop skills in managing safety risks in the design, development, and commercialization of medical devices.
Target Audience:
- Design Engineers, Product Engineers, Development Engineers in the MedTech sector.
- Software Engineers working in medical device development.
- Quality Assurance and Regulatory Affairs professionals.
- Graduate-level Engineering Academics interested in medical devices.
Course Outline:
Introduction to Safety Risk Management in Medical Devices
- Overview of ISO 14971:2019.
- Principles of Safety Risk Management.
- The role of safety risk management in the MedTech sector.
Safety Risk Assessment Practices
- Detailed exploration of risk assessment methodologies.
- Case studies: Analyzing real-world scenarios.
- Group activity: Identifying potential risks in medical device development.
Industry Best Practices and Standards
- Current best practices in safety risk management.
- Aligning with international standards and regulations.
- Workshop: Implementing best practices in safety risk management