ISO 14971 Risk Management for Medical Devices Training Overview

ISO 14971 Risk Management for Medical Devices Training​ Course Outline

Module 1: Introduction to ISO 14971

  • Introduction
  • Scope
  • Terms and Definitions

Module 2: General Requirements for Risk Management

  • Risk Management Process
  • Management Responsibilities
  • Qualification of Personnel
  • Risk Management Plan
  • Risk Management File

Module 3: Risk Analysis

  • Risk Analysis Process
  • Intended Use and Reasonably Foreseeable Misuse
  • Identification of Characteristics Related to the Safety
  • Estimation of the Risk(s) for Each Hazardous Situation

Module 4: Risk Evaluation

  • Overview of Risk Evaluation

Module 5: Risk Control

  • Risk Reduction
  • Risk Control Option Analysis
  • Implementation of Risk Control Measure(s)
  • Residual Risk Evaluation
  • Risk/Benefit Analysis
  • Risks Arising from Risk Control Measures
  • Completeness of Risk Control

Module 6: Evaluation of Overall Residual Risk Acceptability

  • Risk Acceptability

Module 7: Risk Management Review

  • Risk Management
  • Effective Management of Risk

Module 8: Production and Post-Production Activities

  • General
  • Information Collection
  • Information Review
  • Actions

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Who should attend this ISO 14971 Risk Management for Medical Devices Training Course?

Attending this ISO 14971 Risk Management for Medical Devices Training Course can provide attendees with comprehensive insights into Risk Management processes, methodologies, and best practices within the medical device industry. Here are the individuals who might benefit from attending an ISO 14971 Risk Management for Medical Devices Training Course:

  • Medical Device Manufacturers
  • Quality Control Professionals
  • Regulatory Affairs Professionals
  • Risk Management Professionals
  • Clinical Research Professionals
  • Validation and Verification Engineers
  • Biomedical Engineers
  • Legal and Compliance Professionals

Prerequisites of the ISO 14971 Risk Management for Medical Devices Training Course

There are no formal prerequisites for attending this ISO 14971 Risk Management for Medical Devices Training Course.

ISO 14971 Risk Management for Medical Devices Training​ Course Overview

ISO 14971:2019 defines the international requirements of risk management systems for medical devices, including best practices and the entire lifecycle of a medical device. The ISO 14971 standard aims to help manufacturers identify, estimate, evaluate, monitor, and control risks associated with a medical device. ISO 14971 helps organisations to minimise risk by checking whether the control measures were implemented correctly. This ISO 14971 Risk Management for Medical Devices training will allow medical device professionals to successfully improve their business and risk management efforts. Obtaining this training will help individuals to excel in highly reputed jobs and upgraded salaries.

This 1-day ISO 14971 Risk Management for Medical Devices training course provides delegates with a deep understanding of ISO 14971 medical devices concepts. During this training, delegates will learn various concepts such as introduction to ISO 14971, general requirements for risk management, risk management process, management responsibilities, risk analysis process, identification of hazards, risk control, etc. Our highly skilled and professional trainer who has years of experience teaching ISO courses will conduct this training.

They will also cover the following essential concepts such as:

  • Risk management process
  • Terms and definitions
  • Identification of hazards
  • Post-production information
  • Risk management report
  • Qualification of personnel

At the end of this training course, delegates will be able to successfully implement a risk management system within an organisation. They will also be able to estimate the risk(s) for each hazardous situation efficiently.

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What’s included in this ISO 14971 Risk Management for Medical Devices Training Course?

  • World-Class Training Sessions from Experienced Instructors
  • ISO 14971 Risk Management for Medical Devices Training Certificate
  • Digital Delegate Pack

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ISO 14971 Risk Management for Medical Devices Exam Information 

To achieve the ISO 14971 Risk Management for Medical Devices Training, candidates will need to sit for an examination. The exam format is as follows:  

  • Question Type: Multiple Choice  
  • Total Questions: 30  
  • Total Marks: 30 Marks  
  • Pass Mark: 50%, or 15/30 Marks  
  • Duration: 40 Minutes 

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Why choose us

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 14971 Risk Management for Medical Devices Training. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

Unlock your potential with The Knowledge Academy's ISO 14971 Risk Management for Medical Devices Training, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.

What our customers are saying

ISO 14971 Risk Management for Medical Devices Training FAQs

ISO, or the International Standards Organisation, is an independent agency that supplies the organisation's standards. 
There are no formal prerequisites to attend this ISO 14971 Risk Management for Medical Devices training course.
This training course is ideal for anyone who wants to design, develop, and manufacture medical devices within an organisation successfully.
ISO 14971 is an international requirement standard for the application of risk management to medical devices.
The purpose of the ISO 14971 standard is to specify the procedures for controlling the risks associated with medical devices.
In this training, you will cover various concepts such as introduction to ISO 14971, general requirements for risk management, risk management process, management responsibilities, risk analysis process, identification of hazards, risk control, etc.
The training fees for ISO 14971 Risk Management for Medical Devices Training certification in Canada starts from CAD2595
The Knowledge Academy is the Leading global training provider for ISO 14971 Risk Management for Medical Devices Training.
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Resources are included for a comprehensive learning experience.

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"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

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