Global
Ireland
Finland
United Kingdom
United StatesISO 14971 Requirements for Practitioners and Auditors
ISO 14971 Requirements Training for Practitioners and Auditors 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.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. 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.
This course is an internationally accredited credential. CQI and IRCA certify this course (No. 2415) and the Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants.
Overview of our ISO 14971 Requirements Training
What's covered on our ISO 14971 Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- 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
- 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
Case Study! Elements of a Risk Acceptability Policy
- 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)
Case Study! Safety Characteristics
Case Study! Hazard Identification and Sequence of Events
- 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
Case Study! Benefit Risk Analysis
Case Study! Overall Residual Risk
- 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
Case Study! Post-Market Surveillance and Risk
- ISO/TR 24971 Purpose and Structure
- ISO/TR 24971 Annexes
- Annex F Security Risks
- Annex H IVD Medical Devices
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the practical knowledge and be able 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
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
Upon successful completion, each Learner shall receive two digital Certificates of Completion.
The first certificate is issued automatically by Comply Guru within 1hr of the course completion.
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (10).
CQI and IRCA certify this course (No. 2415) under the course title: FD133: MD-QMS ISO 14971:2019 Foundation Training and Learners shall also receive a second training certificate recognized by CQI and IRCA within 2 business days.
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)
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.
Need Corporate, In-House or Customized Training?
Comply Guru offers corporate, in-house and customized training solutions for your organization’s specific needs.
Speak with an experienced member of our team today to learn how we can help.
Not all eLearning is the same
Training Transformed with Comply Guru
What Our Learners Are Saying
4.4
Average Rating
474 global ratings
-
Very comprehensive which great knowledge checks throughout
-
The checks and the end of module tests were a really good way of revising the concepts we learnt. The way that the entire course went step wise through the standard instead of jumping around really helped me understand the risk management process as a whole.
-
Really good course came into it not highly familiar with ISO14971 and really needed to understand Residual Risk. I now feel much more confident in this area and can use this knowledge to improve our internal processes.
-
Overall, my training experience with Comply Guru was very positive. The content was well structured, relevant, and clearly explained, making complex regulatory topics easy to understand.
-
very informative
