- Module 1: Introduction to Risk Management
- Purpose, History, and Structure of ISO 14971,
- Key Changes introduced by ISO 14971 2019
- Key Terminology
- Relationship with ISO 13485, EU MDR 2017 745, EU IVDR 2017 746, and FDA QSR 21 CFR part 820
- Risk Management and the Product Lifecycle
- Module 2: Risk Management Planning
- Risk Management Process
- Risk Management Team
- Role of Top Management
- Risk Management Plan
- Risk Management File
- Module 3: Risk Analysis and Evaluation
- Device Characterization
- Hazards and Hazardous Situations
- Risk Estimation
- Risk Evaluation
- Module 4: Risk Control and Risk Management Techniques
- Risk Management Techniques – PHA, FTA, FMEA HAZOP
- Risk Control Analysis
- AFAP and ALARP
- Implementation of Risk Controls
- Residual Risk
- Benefit-Risk Analysis
- Module 5: Risk Management Review
- Overall Residual Risk Evaluation
- Risk Management Review
- Production and Post-Production Activities
- Module 6: ISO/TR 24971
- Purpose of ISO TR 24971
- Structure of ISO TR 24971
- Overview of Key Annexes
On completion, successful Learners will have the knowledge needed to:
- Explain the history, purpose, and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
- Define the key terminology used throughout ISO 14971
- Describe the elements of an effective risk management process
- Describe the different techniques that support risk analysis
- Explain the requirements for updating the risk assessment based on information collected and reviewed
- Outline the role of ISO TR 24971 in risk management
Who Should Attend?
This course is aimed at anyone working in the medical device sector that wants to gain an understanding of risk management based on ISO 14971 2019, including:
- Design & Development personnel
- Quality / Engineering / Technical / Production personnel
- Regulatory affairs
- Internal / Lead / Supplier Auditors
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
Recommended Prior Learning
Before completing this course, each Learner is recommended to have the following prior knowledge:
- The fundamental concepts and principles of risk management as it applies to medical devices
- The commonly used risk terms and definitions (see ISO 14971)
ISO 13485 Requirements
- A working knowledge of ISO 13485 2016, which may be gained by completing Comply Guru’s ISO 13485 2016 Foundation Course
Upon registering for this course, each Learner will have 90-days of eLearning access to complete the course, including final assessment.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Click here to read the full technology requirements.
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