Lecture 4: Risk Management in ISO 13485

Quality & Standards - Lecture 4: Risk Management in ISO 13485 - 23 slides

Explore Lecture 4: Risk Management in ISO 13485, covering This lecture focuses on the vital role of risk management in ISO 13485, particularly in the context of medical devices..

Topics Covered

• Introduction to ISO 13485 and Risk Management
• Importance of Risk Management in Medical Devices
• Overview of ISO 13485 Risk Management Processes
• Key Definitions in Risk Management
• Understanding Risk in the Context of Medical Devices
• ISO 13485 Risk Management Principles
• Steps in Conducting FMEA
• Identifying Failure Modes in Medical Devices
• Assessing the Effects of Failure Modes
• Real-World Applications of Risk Management in Medical Devices
• Case Study: Successful Risk Management Implementation
• Common Challenges in Risk Management
• ISO 14971 vs ISO 13485: Key Differences
• Emerging Trends in Risk Management for Medical Devices
• Technological Advances Impacting Risk Management
• Future Directions in ISO 13485 Risk Management
• Risk Management Framework in ISO 13485
• Risk Identification: An Overview
• Techniques for Risk Identification
• Failure Mode and Effects Analysis (FMEA) Overview
• Risk Assessment: Qualitative vs Quantitative
• Tools and Techniques for Risk Assessment
• Summary of Key Concepts

References

• ISO (2016) ISO 13485:2016 Quality Management Systems for Medical Devices. Geneva: ISO.
• ISO (2019) ISO 14971:2019 Application of Risk Management to Medical Devices. Geneva: ISO.
• FDA (2020) Device Recall Overview. Available at: https://www.fda.gov.
• Deming, W.E. (1950) Quality Improvement Loop.
• ISO (2019) Risk Management Terms in ISO 14971. Geneva: ISO.
• FDA (2023) Human Factors for Medical Devices. Available at: https://www.fda.gov.
• Nielsen J (1992) Usability Engineering. Experience balancing storied medical complications.
• IEC 60812 (2018) Failure modes and effects analysis (FMEA) procedures.
• Dhillon, B.S. (1999) Engineering risk assessment. Boca Raton: CRC Press.
• FDA (2016) Applying Human Factors and Usability Engineering to Medical Devices.
• Norman, D.A. (2013) The design of everyday things. Rev. ed. New York: Basic Books.
• ISO/TR 24971:2020 Guidance on risk management.
• ISO (2016) ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.
• FDA (2021) Medical Device Risk Management Guidelines.
• AIAG (1993) Failure Mode and Effect Analysis Manual.
• ISO (2016) ISO 13485 - Medical Device Guidelines.
• FDA (2020) Device Post-Market Risk Management Strategy Guidelines.
• ISO (2016) ISO 13485 Risk Methods Toolbox.
• ISO 14971:2019. Application of risk management to medical devices.
• ISO 13485:2016. Medical devices - Quality management systems - Requirements for regulatory purposes.
• KPMG Healthcare IoT report (2020).
• FDA Post-market cybersecurity guidelines (2018).
• IBM Watson Case Study (2021)
• Blockchain for medical innovation: Deloitte Insights (2020).
• WHO Guidelines: Biotech Futures (2022)
• ISO (2016) ISO 13485: Medical devices — Quality management systems. ISO.
• AAMI (2020) Risk Management for Medical Devices. Arlington, VA: AAMI Press.
• IEC (2021) IEC 31010: Risk Management - Risk Assessment Techniques.
• Stamatis, D.H. (2003) Failure Mode and Effect Analysis. Milwaukee, WI: ASQ Quality Press.
• ISO (2018) ISO/IEC 31010: Risk management — Risk assessment techniques. ISO.