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United StatesISO 14971 Training that provides a comprehensive overview of the international standard for risk management for medical devices. This course has been specifically designed for Quality & Regulatory Professionals in the Medical Device Industry.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Course Overview
ISO 14971 Foundation Training
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
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
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, including:
- Design & Development personnel
- Quality / Engineering / Technical / Production personnel
- Regulatory affairs
- Internal / Lead / Supplier Auditors
CQI & IRCA certify this course (No. 2415). Upon successful completion, each Learner shall receive a digital Certificate of Completion 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) within the 90-day course license
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. Read the full technology requirements here.
Why Choose Comply Guru
About our ISO 14971 Training
Learn about how our Accredited ISO 14971 Training is leading the industry for innovation through online learning
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.4
Average Rating
425 global ratings
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It took a lot of time but was very informative and helpful.
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Love the e-training and the flexibility that it offers and that I can do it on my own time. This is what makes me select ComplyGuru trainings.
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Well laid out course and clear instructions on how to use the course content. Good training experience for an introduction level.
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It was good
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Course was well laid out with well paced comprehension exams.
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