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ISO 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.

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.

CQI & IRCA certify this course (No. 2415) and the Regulatory Affairs Professionals Society (RAPS) recognize this course offering global recognition for successful participants.

CQI-IRCA Cretified Course RAPS Cretified Course
ISO 14971 Requirements for Practitioners and Auditors
 
Course Snapshot
Approved By
CQI & IRCA (No. 2415) and the Regulatory Affairs Professionals Society (RAPS)
RAPS Credits
10
Duration
10hrs
Teaching Format
eLearning
Certification of Completion
Yes
Language (s)
English
Price Limited Time
€695.00 €495.00
Learner Rating
★★★★★ 449 Reviews

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

eLearning Module Breakdown & Timings

An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.

Time Topic
75mins eLearning

Module 1: 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
90mins eLearning

Module 2: 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

Case Study! Elements of a Risk Acceptability Policy
120mins eLearning

Module 3: 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)

Case Study! Safety Characteristics

Case Study! Hazard Identification and Sequence of Events
90mins eLearning

Module 4: 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

Case Study! Benefit Risk Analysis

Case Study! Overall Residual Risk
75mins eLearning

Module 5: 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

Case Study! Post-Market Surveillance and Risk
90mins eLearning

Module 6: ISO/TR 24971

  • ISO/TR 24971 Purpose and Structure
  • ISO/TR 24971 Annexes
  • Annex F Security Risks
  • Annex H IVD Medical Devices
40mins

Certification Exam

  • 40 MCQ-based eAssessment with 70% or higher required to achieve certification

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

ISO 14971 Requirements Training

Learning Objectives Covered

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

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
Course Certification

CQI IRCA

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.

RAPS Approved Provider Logo

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.

What Are The Entry Requirements

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
How You Are Assessed

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)
What Are The Technology Requirements

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 Globally Recognized ISO 14971 Training is leading the industry for innovation through online learning

 
About Our Course
 
Why Choose eLearning

Customer Reviews

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
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.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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Globally Recognized Qualifications
Training credentials that you can trust.
CQI & IRCA Approved Training Provider
Exemplar Global Recognized Training Provider
RAPS Recertification Approved Provider