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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Mississauga is the sixth largest city in Canada. It is in the south of the province of Ontario in the region of peel. The city is estimated to have a population of around 715,000 people. The rapid growth of this city is attributed to its proximity to Toronto. It was originally built as suburb of Toronto. 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. Mississauga is served by the Peel District School Board, which operates the secular English speaking public schools. There is also a school board that runs the local catholic schools and a board that runs the French speaking schools in the area, one for the secular French schools and one for the catholic French schools. There are a number of schools in the area that offer specialised programs. These include the French immersion schools such as Clarkson Secondary School and Streetsville Secondary School. There are three schools in the areas that off a Regional Arts Program and two that offer a specialist sci-tech program for students who are gifted in these areas. There is also two schools that offer support for those studying for the international baccalaureate plus numerous other programs. 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. Mississauga is home to one of the three campuses run by the University of Toronto. This university is ranked as the 34th best university in the world and is the second highest ranked Canadian university in the rankings. The campus was established in 1967 and is the universities second largest division. It is home to 12,000 students. They have 15 academic departments and pupils can choose from 148 programs to participate in from 89 areas of study. Students can study both undergraduate and graduate programs on this campus. This campus also has an excellent research environment that has helped the staff and researchers become internationally recognised for their work. The university includes Institutes for Management and Innovation, and Communication, Culture, Information and Technology.

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Address

Robert Speck 2
2 Robert Speck Parkway
Suite 750
Mississauga
Ontario
L4Z 1H8

T: +1 6474932992

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 Mississauga. 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 Mississauga, 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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ISO 14971 Risk Management For Medical Devices Training | ISO Training in Mississauga 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 Mississauga starts from CAD2595
The Knowledge Academy is the Leading global training provider for ISO 14971 Risk Management for Medical Devices Training.
Please see our ISO Certification courses available in Mississauga
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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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