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Course Information

ISO 14971 Risk Management for Medical Devices Training​ Course Outline

Module 1: Introduction to ISO 14971

  • 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 Identification of Characteristics Related to the Safety of the Medical Device
  • Identification of Hazards
  • Estimation of the Risk(s) for Each Hazardous Situation

Module 4: 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 Management Report
  • Production and Post-Production Information

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Prerequisites 

There are no formal prerequisites to attend this ISO 14971 Risk Management for Medical Devices training course. 

Audience

This training course is ideal for anyone who wants to design, develop, and manufacture medical devices within an organisation successfully.

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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  • Delegate pack consisting of course notes and exercises
  • Courseware
  • Experienced Instructor

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Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

This is our most popular style of learning. We run courses in 1200 locations, across 200 countries in one of our hand-picked training venues, providing the all important ‘human touch’ which may be missed in other learning styles.

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Highly experienced trainers

All our trainers are highly qualified, have 10+ years of real-world experience and will provide you with an engaging learning experience.

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State of the art training venues

We only use the highest standard of learning facilities to make sure your experience is as comfortable and distraction-free as possible

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Small class sizes

We limit our class sizes to promote better discussion and ensuring everyone has a personalized experience

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Great value for money

Get more bang for your buck! If you find your chosen course cheaper elsewhere, we’ll match it!

This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.

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Tailored learning experience

Our courses can be adapted to meet your individual project or business requirements regardless of scope.

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Maximise your training budget

Cut unnecessary costs and focus your entire budget on what really matters, the training.

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Team building opportunity

This gives your team a great opportunity to come together, bond, and discuss, which you may not get in a standard classroom setting.

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Monitor employees progress

Keep track of your employees’ progression and performance in your own workspace.

What our customers are saying

Frequently asked questions

FAQ's

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 price for ISO 14971 Risk Management for Medical Devices Training certification in Philippines starts from $1295
The Knowledge Academy is the Leading global training provider in the world for ISO 14971 Risk Management for Medical Devices Training.
Please see our ISO Training courses available in Philippines

Why choose us

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Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

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Many delivery methods

Flexible delivery methods are available depending on your learning style.

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High quality resources

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"

Joshua Davies, Thames Water

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