ISO 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.
Key Course Information
What you need to know?
Our industry-leading Online Training is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
On completion of this course, 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
A summary of learning topics within this course include:
- Purpose, History, and Structure of ISO 14971
- Key Changes introduced by ISO 14971:2019
- Key Terminology
- Relationship with ISO 13485, EU MDR, EU IVDR, and FDA QSR 21 CFR part 820
- Risk Management and the Product Lifecycle
- Risk Management Process
- Risk Management Team
- Role of Top Management
- Risk Management Plan
- Risk Management File
- Device Characterization
- Hazards and Hazardous Situations
- Risk Estimation Evaluation
- Risk Management Techniques – PHA, FTA, FMEA HAZOP
- Risk Control Analysis
- Implementation of Risk Controls
- Residual Risk
- Benefit-Risk Analysis
- Overall Residual Risk Evaluation
- Risk Management Review
- Production and Post-Production Activities
- Purpose & Structure of ISO/TR 24971
- Overview of Key Annexes
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, including:
- Design & Development personnel
- Quality / Engineering / Technical / Production personnel
- Regulatory affairs
- Internal / Lead / Supplier Auditors
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
CQI & IRCA certify this course (No. 2415). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their digital Certificate of Completion.
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.
Frequently Asked Questions
Reviews & Ratings
386 global ratings
The content was presented very well. It was easy to understand and follow.
Very informative course.
It was great!
The course was thorough and detail the important points of the standard.
I gained good knowledge. This training was really informative. I liked how it was formatted with good examples.
Good high level overview on application of risk management process
Good course to complete.
The course was clean and well delivered.
The quality of the training is excellent and thorough. The narration and videos are well done. This is some of the best training I have ever had.