Online ISO 14971 Training | CQI, IRCA & Exemplar Global Certified
Online ISO 14971 Training (CQI & IRCA Certified) 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 8hr eLearning course 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.
This Online ISO 14971 Foundation Training course is available via eLearning (24/7) offering you the most convenient & flexible way to learn online, anytime, anywhere. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience and learning style.
Learning Objectives
On completion of this Online ISO 14971 Training, 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
Course Content
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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
Entry Requirements
Before completing this course, each Learner is recommended to have the following prior knowledge:
Risk Management
- 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, which may be gained by completing Comply Guru’s ISO 13485 Foundation Course
Assessment & Certification
Methodology
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
Certification
CQI & IRCA certify our ISO 14971:2019 Foundation Training Course (No. 2415). Successful completion will entitle each Learner to receive a digital Recognized Certificate of Completion.
Reviews & Ratings
4.3
Average Rating
365 global ratings
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I gained good knowledge. This training was really informative. I liked how it was formatted with good examples.
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Good high level overview on application of risk management process
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Good course to complete.
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The course was clean and well delivered.
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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.
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Very thorough
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Very useful-I wish I had done the course earlier!
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The content was concise, easy to understand & very educational.
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I'd recommend this course to anyone starting a new job in the regulatory field. I'm glad I did it.
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Easy to access, self-paced, clear ability to pick up where I left off. Would recommend for remote training.