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Interpreting and Applying ISO 14971 Risk Management
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Learn to interpret and apply the risk management requirements to your products.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
Post Learning Implementation Plan (PLIP)
Pre-course
- Access to the Educo Training Portal
- Submit your needs analysis and objectives for training by completing a simple online form
Action Plan
- At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge
Reinforcement Session
- Delivered 3 to 4 weeks after the training
- It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1 & 2
Overview of risk management for Medical Devices IVDs
- What is required by ISO 13485:2016
- Formal systems: Best Practice for document control and record keeping
Risk management and the Medical Device Regulation (MDR)
- Responsibilities of the manufacturer
- Examine relevant articles and clauses in the MDR
- Safety and performance requirements under the MDR
- Risk management and the design control process
Module 3
Review of the ISO 14971:2019 standard and relevant guidance documents
- Introduction to ISO 14971:2019
- Definitions and terminology
- Including practical elements this session will cover
- Overview of the standard including structure and definitions
- Risk management planning: Top down and bottom up
- Risk evaluation
- Creating a risk management report
- Risk control and mitigation
- Benefit vs risk analysis
Module 4
Guidance and application of usability engineering EN ISO 62366 1 & 2:2015
- Discussing human factors, perception, rationalisation and instructions for use.
- Applying a critical risk management input
- Validation of human factors such as interfaces and alarms
- Understanding refusal to accept policies
Module 5
Medical device risk management tools – Practical session
This session will focus on practically implementing different risk management tools in the context of a product life cycle.
- Hazard analysis and critical control point (HACCP)
- Qualitative severity
- FMEA, Fault tree analysis and SWIFT
Module 6
Risk management linkages with other regulatory elements: Integrated Risk Management
- Examine ISO 14971:2019 and ISO 13485:2016
- Learn how risk management links with the QMS
- Measuring the cause of risk
- Post market feedback and risk management
- Clinical evidence and risk management
- Examine the clinical evaluation
- Reviewing when a clinical investigation is needed
- Risk management and post market surveillance and vigilance activities
Module 7
ISO 13485:2016 and the implementation of a Quality Management System (QMS)
- Overview of risk within ISO 13485
- Learn how the QMS links into the risk management system
- Assessing risk in QMS processes
- Recording, documenting and risk assessing processes in a QMS, principals of document control
- EUMDR Annex II and Technical Documentation
Module 8
Critical reference standards for medical device risk management
- Biological Evaluation – EN ISO 10993-1
- Electrical Safety and Performance Standards – IEC 60601
- Cleanroom Standards – ISO 14644
- Sterilisation and Packaging Standards
Richard Young has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.
Richard has delivered online and classroom training courses on risk management for both devices and IVDs. He can provide multiple examples and case studies during training, drawing on his extensive industry experience.
This course is suitable for professionals who are involved in risk management of their device or diagnostic (IVD) product. These include: Regulatory Affairs | Quality | Design & Development | Engineers | Management | Device Manufacturers.
