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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New Delhi is one of the districts within Delhi, as well as it being the capital city of India, it is also the home to the Government of the National Capital Territory of Delhi and some of the branches of the Government of India, these being the judiciary, executive and legislative branches and is also home to around 249,998 people. The capital of India - New Delhi was initiated within 1931 by Viceroy Lord Irwin however formed during 1911 by George V, who was the King of the United Kingdom as well as the Emperor of India and his British architects Sir Herbert Baker and Sir Edwin Lutyens formed the foundation stone and announced the capital city of India would be changed. The primary schools and secondary schools within New Delhi are either run privately or by the government and as of 2004 to 2005 there was around 1.5 million students going through the educational system within 2416 primary schools, 822,00 students in 715 middle schools and 669,000 students in 1576 secondary schools and around 500,000 students within 165 universities and colleges. All universities are either state, deemed or central universities, The top universities within New Delhi are the Jamia Millia Islamia, the University of Delhi, Indian Statistical Institute, National Law University, Jawaharlal Nehru University, Guru Gobind Singh Indraprastha University, Ambedkar University Delhi, Jamia Hamdard, Delhi Technological University – which is the first Engineering college within Delhi and one of the oldest in India, the Indira Gandhi National Open University is the largest national university in the world with over 4 million students, New Delhi is also home to the Indian Agricultural Research Institute, Pusa, New Delhi, Premier institute for agricultural research and education in India. The university courses and programs can offer different types of degrees such an undergraduate and post graduate courses, Bachelor courses and Scholarships, New Delhi prides itself on its premier institutions as the teaching and researching they do means that within 2011 the census recorded the literacy rate for females as 80.9% and for males it was slightly higher at 91.0% with an overall literacy rate of 86.3%. Subjects within the different universities can include, social sciences, engineering, humanities, technology, sports, law, social work, arts, management, education, computer information technology, foreign languages, mathematical science, dentistry and medical. 

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Pioneer Institute of Education and Computer Studies
F322/A, 3rd Floor
Adarsh House (Above PNB Bank)
Old MB Road
Lado Sarai
New Delhi
110030

T: +91 8037244591

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 New Delhi. 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 New Delhi, 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.

Experience the most sought-after learning style with The Knowledge Academy's ISO 14971 Risk Management For Medical Devices Training | ISO Training in New Delhi. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 14971 Risk Management For Medical Devices Training | ISO Training in New Delhi sessions.

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