Course information

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

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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Video equipment

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Ottawa is the capital city of Canada. It is located on the bank of the Ottawa River in the east of Southern Ontario province. It has an estimated population of 885,000 people. Ottawa is the fourth largest city in the world. The name of this city comes from the Algonquin word Odawa which means “to trade”. Education in Canada is mostly free and publicly funded. It is overseen by the federal, provincial and local governments, with the education within provincial jurisdiction and the curriculum overseen by the province. Education is compulsory in most provinces up to the age of 16. Parents can choose between sending their children to one of the public schools or they can sent them to a fee paying private school. Those who live in Ottawa and find that picking a secondary school is a fraught decision involving school zones and ratings. There are four main public school boards in Ottawa. One is English, one is English-Catholic, and one is French and another is French-Catholic. The Ottawa-Carleton District School Board which is the largest with 147 schools to oversee. The catholic school board has 85 schools, the Conseil des écoles catholiques du Centre-Est has 49 schools and the Conseil des écoles publiques de l'Est de l'Ontario has 37 schools. Canada’s higher has a very good reputation. However there is no formal ranking system and students will often choose colleges and universities bases on geographic convenience and the reputation of a particular course. Ottawa is one of the best educates cities in Canada as it is believed that over half of the population have graduated from college or university. Ottawa has the highest per capita concentration of engineers, scientists, and residents with PhDs in Canada. The University of Ottawa was founded in 1848 and was the first higher education institute to be established in the city.  The university is a bilingual public university. The University of Ottawa is ranked in the top 300 universities in the world, coming in at number 284 and is a top 15 university in Canada.  The university has faculties in the following areas: arts, civil law, common law, education, engineering, post graduate studies, health sciences, medicine, science, social sciences and the school of management. Ottawa also has two main public colleges Algonquin College and La Cité collégiale. There are also 2 catholic universities in the city; Dominican University College and Saint Paul University.

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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 | ISO Training in Ottawa. 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 | ISO Training in Ottawa, 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.

Streamline large-scale training requirements with The Knowledge Academy's In-house/Onsite at your business premises. Experience expert-led classroom learning from the comfort of your workplace and engage professional development.

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Tailored learning experience

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Team building opportunity

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ISO 14971 Risk Management For Medical Devices Training | ISO Training in Ottawa 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 Ottawa 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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"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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