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8hrs Online Course USD $ 695.00 ★★★★★ 386 Reviews

ISO 14971 Training 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.

Why Comply Guru?

  • CQI, IRCA & Exemplar Global Certified
  • Self-Paced, On-Demand Learning (24/7)
  • Highly Interactive, Engaging Experience
  • Industry-leading Methodology
  • Designed by Experts with Proven Expertise
ISO 14971 Foundation Training

Key Course Information

What you need to know?

Our industry-leading Online Training 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.

Available Formats:

eLearning

eLearning

Customized Learning

Customized Learning

Learning Objectives Module Content Who Should Attend? Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

On completion of this course, 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

Module Content

A summary of learning topics within this course include:

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

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:

  • 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

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

Course Accreditation

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.

Exemplar Global

Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their digital Certificate of Completion.

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.

Pricing

Gain an Internationally Accredited ISO 14971 Certification

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Secure Payment

Individual
USD $ 695.00
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Team of 5
USD $ 3300.00
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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.
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.
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