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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Dallas is a large city in the state of Texas, USA. It is most famous for its oil and cotton industries and its busy railroad lines. The city has population of around 1,300,000 people and is home to a large amount of Fortune 500 companies. In Dallas, there are 337 public schools, almost 90 private schools and 38 colleges. Dallas is the centre of education in the southern central United States. The University of Texas Southwestern Medical School is an exclusive medical school admitting only about 200 students per year. Other universities include Texas Women’s University which is a nursing school located in Parkland Memorial Hospital, and Dallas Baptist University which is a private university that offers Biblical and Christian subjects. It enrols around 5,500 people and provides students with graduate, doctoral and undergraduate degrees. Criswell College is a university started by the First Baptist Church of Dallas in the 1970s, also offering Biblical studies and has around 400 students enrolled currently. Dallas Theological Seminary offers students seminaries in the evangelical faith and boasts an alumni of around 12,000 people. There are a number of universities in the close proximity of Dallas including The University of Dallas in Irving and the El Centro College. El Centro College was established in 1966 and has a student population of around 10,000 students and as is one of the only universities in Dallas which offers fashion design and marketing programs as well as food hospitality programs. The main school district of Dallas is the Dallas Independent School District which enrols over 160,000 students.  The School for the Talented and Gifted in Dallas was voted the best school in the United States numerous times and another Dallas school, the Science and Engineering Magnet has been named number two in the very same list on numerous occasions. There are a high number of private schools in Dallas, including The Hockaday School, Burton Adventist Academy, Parish Episcopal School, The Winston School, Yavneh Academy of Dallas and Dallas Lutheran School.

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Address

15455 Dallas Parkway, Suite 600,

Addison, Texas 75001.

T: +1 7204454674

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 Dallas. 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 Dallas, 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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