ISO 14971 Risk Management For Medical Devices Training | ISO Training in Christchurch

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ISO 14971 Risk Management for Medical Devices Training

Christchurch

Learn how ISO 14971 can improve a business and risk management efforts.
Become familiar with the evaluation of overall residual risk acceptability.
Gain an in-depth understanding of risk analysis, evaluation, and control.

Dates & Prices Dates & Prices

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

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.

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

Why choose us

Our Christchurch venue

Includes..

Free Wi-Fi

To make sure you’re always connected we offer completely free and easy to access wi-fi.

Air conditioned

To keep you comfortable during your course we offer a fully air conditioned environment.

Full IT support

IT support is on hand to sort out any unforseen issues that may arise.

Video equipment

This location has full video conferencing equipment.

Christchurch is the largest city in the south island of New Zealand and has a population of around 350,000. Christchurch has several educational institutes including primary, secondary, college and Universities. Christchurch is home to Burnside High School which is the fourth largest school in New Zealand, and houses over 2,500 students. Cashmere High School is also another large secondary school. Another secondary school of similar size is Papanui High School. Christchurch is very well known for its traditional schools, for example, St Thomas of Canterbury College and St Andrew’s College. Christchurch has a number of Universities and Institutes located in or around the city. The University of Canterbury is New Zealand’s second oldest University. The University was founded in 1873 and became the second institution in New Zealand to offer tertiary level education. The University of Canterbury offers degrees in various departments such as, Social Work, Fine Arts, Education and Sports Coaching. The University currently has around 14,900 students in attendance, with 10,000 undergraduates and 2000 post graduates. Another institute located in Christchurch is the Christchurch Polytechnic Institute of Technology which provides students with full and part time education in technologies and trade. Christchurch Polytechnic Institute of Technology is the largest institute on the island to offer Applied Sciences. The University has around 25,000 full and part time students in attendance. The University offers degrees in departments such as: Music Arts, Nursing, Applied Science and Information Technology. The University Of Otago Christchurch School Of Medicine is also located in Christchurch and is one of three schools that make up the University of Otago and is primarily based at Christchurch Hospital. The University of Otago Christchurch School Of Medicine was established in 1924 and became a clinical school in 1973. The school is linked with the University Of Otago Dunedin School Of Medicine, where students can choose to study their final year there.

Address

Pavilions Hotel Church
42 Papanui Rd
Merivale
Christchurch
8014

T: +64 98874342

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 Christchurch. 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.

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Unlock your potential with The Knowledge Academy's ISO 14971 Risk Management For Medical Devices Training | ISO Training in Christchurch, 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.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 14971 Risk Management For Medical Devices Training | ISO Training in Christchurch. 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 Christchurch sessions.

Highly experienced trainers

Boost your skills with our expert trainers, boasting 10+ years of real-world experience, ensuring an engaging and informative training experience

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

Small class sizes

Our Classroom courses with limited class sizes foster discussions and provide a personalised, interactive learning environment

Great value for money

Achieve certification without breaking the bank. Find a lower price elsewhere? We'll match it to guarantee you the best value

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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.

Tailored learning experience

Leverage benefits offered from a certification that fits your unique business or project needs

Maximise your training budget

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

Team building opportunity

Our offers a unique chance for your team to bond and engage in discussions, enriching the learning experience beyond traditional classroom settings

Monitor employees progress

The course know-how will help you track and evaluate your employees' progression and performance with relative ease

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What our customers are saying

Joy was very well spoken and connected through the course; he gave strong delivery of the material in for the best benefit to learn. Joy also did a good job working with my technical issues during the class.

Brook-Lynn Marie

ISO 14971 Risk Management For Medical Devices Training | ISO Training in Christchurch FAQs

What is ISO? 

ISO, or the International Standards Organisation, is an independent agency that supplies the organisation's standards. 

What are the prerequisites?

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

Who should attend this course?

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

What is ISO 14971 standard?

ISO 14971 is an international requirement standard for the application of risk management to medical devices.

What is the purpose of ISO 14971?

The purpose of the ISO 14971 standard is to specify the procedures for controlling the risks associated with medical devices.

What will I learn in this ISO 14971 Risk Management for 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.

What is the cost/training fees for ISO 14971 Risk Management for Medical Devices Training certification in Christchurch?

The training fees for ISO 14971 Risk Management for Medical Devices Training certification in Christchurch starts from NZD3095

Which is the best training institute/provider of ISO 14971 Risk Management for Medical Devices Training in Christchurch?

The Knowledge Academy is the Leading global training provider for ISO 14971 Risk Management for Medical Devices Training.

What are the best ISO Certification courses in Christchurch?

Please see our ISO Certification courses available in Christchurch

Why choose us

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.

Many delivery methods

Flexible delivery methods are available depending on your learning style.

High quality resources

Resources are included for a comprehensive learning experience.

"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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