Online ISO 14971 Foundation Training | CQI & IRCA Certified

eLearning Modules

• Purpose, History, and Structure of ISO 14971
• Key Changes introduced by ISO 14971:2019
• Key Terminology
• Relationship with ISO 13485, EU MDR 2017 745, EU IVDR 2017 746, 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
• Risk Evaluation
• Risk Management Techniques – PHA, FTA, FMEA HAZOP
• Risk Control Analysis
• AFAP and ALARP
• Implementation of Risk Controls
• Residual Risk
• Benefit-Risk Analysis
• Overall Residual Risk Evaluation
• Risk Management Review
• Production and Post-Production Activities
• Purpose of ISO/TR 24971
• Structure of ISO/TR 24971
• Overview of Key Annexes

On completion of this Online ISO 14971 Foundation Training, successful Learners will have the knowledge needed to:

1. Explain the history, purpose, and structure of ISO 14971 and its relationship to ISO 13485 and the EU & US FDA regulations
2. Define the key terminology used throughout ISO 14971
3. Describe the elements of an effective risk management process
4. Describe the different techniques that support risk analysis
5. Explain the requirements for updating the risk assessment based on information collected and reviewed
6. Outline the role of ISO TR 24971 in risk management

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: 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

ISO 14971 Training Assessment 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

ISO 14971 Training 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.

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 full technology requirements

In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.