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United StatesAdvanced 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.
Course Overview
Advanced Risk Practitioner
Introduction to Risk Management
- 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
Risk Management Planning
- 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
Risk Assessment
- 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)
Risk Control
- 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
Risk Management Review and Update
- 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
ISO/TR 24971
- ISO/TR 24971 Purpose and Structure
- ISO/TR 24971 Annexes
- Annex F Security Risks
- Annex H IVD Medical Devices
1-day of Practical Workshops working with Case Studies covering:
- Ready to Use Risk Management Tools & Techniques
- Preliminary Hazard Analysis (PHA)
- FMECA
- HAZOP
- Fault Tree Analysis (FTA)
- Application of Risk Management to Software Risks
- Practical Implementation Tools & Techniques
- Application to the Product Lifecycle
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
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
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