ISO 14971 Training (Foundation) 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 for are new to the Standard.

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.

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Course Snapshot
Accreditation
CQI & IRCA (No. 2415)
Duration
8hrs
Available Format
eLearning
Price
GBP £  495.00
Learner Rating
★★★★★ 425 Reviews
Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Learn Anywhere, Anytime
Course Access for 6 Months
Ask The Instructor
Minimize Downtime at Work
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+

Course Overview

ISO 14971 Training (Foundation)

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

What This Course Covers Covered

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

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

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)

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

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

ISO/TR 24971

  • ISO/TR 24971 Purpose and Structure
  • ISO/TR 24971 Annexes
  • Annex F Security Risks
  • Annex H IVD Medical Devices
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 Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2415). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.

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) within the 90-day course license
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.

About our ISO 14971 Foundation Training

Learn about how our IRCA Accredited ISO 14971 Training is leading the industry for innovation through online learning

 
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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.
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 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.
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.
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.
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.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020