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United StatesAdvanced Risk Practitioner (ISO 14971) for Medical Devices
Advanced Risk Practitioner Training (Medical Devices) is for anyone who wants both a comprehensive overview of the international standard for risk management for medical devices, and to acquire the best practice skills to readily apply the knowledge and tools successfully within their organization.
Our blended learning course is a hybrid approach where you first complete eLearning modules on the underlying theory that better prepares you in advance of attending Live Classes with an Instructor where Learners will work with case studies & scenarios that help deepen the understanding of the requirements, and applying the tools & techniques in a real life context.
The Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants and RAPS credits for members.
Overview of our Advanced Risk Practitioner (ISO 14971) Training
What's covered on our Advanced Risk Practitioner Training
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
- Risk Management and Product Lifecycle
- Risk Perception
- Introduction to ISO 14971
- ISO 14971:2019 Key Changes
- Structure of ISO 14971
- Key Terminology
- Medical Device Regulatory Framework
- Product and Process Standards
- Clause 4 Overview
- Risk Management Process
- Risk Acceptability Policy
- Risk Management Process Review
- Risk Management Team Competency
- Expert Training
- Risk Management Plan
- Risk Management File
Case Study! Elements of a Risk Acceptability Policy
- Risk Assessment Overview
- Risk Analysis Process
- Intended Use
- Reasonably Foreseeable Misuse
- Safety Characteristics
- Hazards and Hazardous Situations
- Types of Hazards
- Sequence of Events
- Random & Systematic Faults
- Risk Estimation
- Risk Evaluation
- Risk Analysis Tools
- Preliminary Hazard Analysis (PHA)
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
- Hazard and Operability Study (HAZOP)
- Hazard Analysis and Critical Control Point (HACCP)
Case Study! Safety Characteristics
Case Study! Hazard Identification and Sequence of Events
- Risk Control
- Risk Reduction
- Risk Control Analysis
- Role of Standards in Risk Control
- Implementation
- Residual Risk Evaluation
- Benefit-Risk Analysis
- New Risks
- Risk Control Completeness
- Overall Residual Risk
- Disclosure of Significant Residual Risks
Case Study! Benefit Risk Analysis
Case Study! Overall Residual Risk
- Risk Management Review
- Production and Post-Production Activities
- Information Collected
- Information Review
- Actions
- Relationship between ISO 13485 and ISO 14971
- ISO 14971 and Design & Development
Case Study! Post-Market Surveillance and Risk
- ISO/TR 24971 Purpose and Structure
- ISO/TR 24971 Annexes
- Annex F Security Risks
- Annex H IVD Medical Devices
- Risk Management terms and definitions
- Alignment with ISO 13485 and Regulatory Frameworks
Practical Workshop! Integrating Risk Assessment Tools into the ISO 14971 Process
- General Requirements
- Roles and Responsibilities in the Risk Management Process
- Documentation Requirements: Risk Management File (RMF)
Practical Workshop! Building a Comprehensive Risk Management File (RMF)
- Identifying hazards and hazardous situations
- Determining foreseeable misuse
- Conducting risk estimation
- Tools and Techniques: FMEA, Fault Tree analysis
Practical Workshop! Using FMEA for Risk Identification and Estimation
- Risk Acceptance Criteria
Practical Workshop! Setting and Applying Risk Acceptance Criteria
- Risk Control Options
- Evaluating residual risks
- The risk-benefit analysis process
Practical Workshop! Verifying the effectiveness of Risk Control
- Monitoring and feedback mechanisms
- Post-market surveillance and vigilance
- Continuous improvement in risk management
Practical Workshop! The Role of Post-market Surveillance in Risk Management
Michelle Keane
On completion of this course, successful Learners will have the practical knowledge to support their organization and apply the techniques needed to:
- Explain the purpose and scope of ISO 14971
- Outline the steps to establish, document and maintain a risk management process
- Analyze risk evaluation techniques and criteria in compliance with ISO 14971
- Apply risk control measures to reduce residual risks effectively
- Conduct post-market surveillance and continuous risk monitoring
This course is aimed at anyone working in the medical device sector that wants to master risk management based on ISO 14971, including:
- Design & Development personnel
- Quality / Engineering / Technical / Production personnel
- Regulatory affairs
- Internal / Lead / Supplier Auditors
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (12).
Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
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)
- A working knowledge of ISO 13485, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
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)
- Fully attend the Live Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the 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. Read the full technology requirements here.
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Frequently Asked Questions
Blended Learning is Better Learning
Training Transformed with Comply Guru
What Our Learners Are Saying
4.5
Average Rating
14 global ratings
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Very good course, well delivered by Micehelle and really enjoyed the interactive theory element.
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I have complteed several training courses with Comply Guru and always find them to be well structured with excellent delivery from knowledgeable instructors.
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Dashboard etc was very good. use of break out rooms good to help us connect with other learners.
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The elearning piece was informative and had a lot of interactive exercises to promote learning of standard. The workshop days were mostly break out room activities which were similar to elearning. It did not offer industry examples of a good or bad risk templates which we could interrogate.
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This training was very effective, I feel much more comfortable in my knowledge of ISO 14971 and it's applications for risk management. Michelle is brilliant in her delivery of these courses, keeping everyone engaged throughout. The breakout rooms are a great element too.
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