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ISO 14971 Risk Management for Medical Devices Training Overview
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 outlines Risk Management principles specific to medical devices, ensuring their safety and efficacy throughout their lifecycle. Its relevance lies in minimising potential hazards, ensuring patient safety, and complying with regulatory requirements in developing and maintaining medical devices.
Proficiency in ISO 14971 is crucial for Medical Device Manufacturers, Regulatory Affairs Professionals, and Quality Assurance Experts. Mastery of this standard enables them to establish robust risk management processes, assess and mitigate risks associated with medical devices, and ensure compliance with regulatory standards, which is critical for delivering safe and effective medical devices to the market.
This 1-day Training immerses delegates in ISO 14971's principles, covering risk management methodologies, hazard analysis, and risk assessment techniques specific to medical devices. Delegates gain insights into implementing effective risk management strategies, ensuring device safety, and complying with regulatory standards, empowering them to navigate complex risk scenarios in medical device development.
Course Objectives
- To implement robust risk management processes in medical device development
- To assess and mitigate risks associated with medical devices
- To ensure compliance with regulatory standards in device development
- To enhance patient safety through effective risk management strategies
- To navigate complex risk scenarios in medical device development
Delegates completing this ISO Certification Course will possess comprehensive expertise in ISO 14971, enabling them to implement robust risk management processes specific to medical devices. They'll also be equipped to assess, mitigate, and manage risks effectively.
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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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. 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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Join a scheduled class with a live instructor and other delegates.
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Engage in activities, and communicate with your trainer and peers.
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Unlock your potential with The Knowledge Academy's ISO 14971 Risk Management for Medical Devices Training, 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.
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 FAQs
ISO (International Organisation for Standardisation) is a globally recognised body that develops and publishes international standards to ensure quality, safety, efficiency, and interoperability across various industries. These standards help organisations improve their processes and meet customer expectations.
ISO 14971 is the international standard that outlines the process for managing risks associated with medical devices. It provides a framework for identifying, assessing, controlling, and monitoring risks throughout the product lifecycle to ensure device safety and compliance with regulatory requirements.
Yes, ISO 14971 is harmonised with the Medical Device Regulation (MDR). This means that compliance with ISO 14971 can help meet the risk management requirements outlined in MDR, making it essential for manufacturers looking to bring their medical devices to market in the European Union.
While ISO 14971 is not strictly required for ISO 13485 compliance, it is highly recommended. ISO 13485 focuses on quality management systems for medical devices, and ISO 14971 provides a comprehensive approach to managing risk, which complements the quality standards in ISO 13485.
ISO refers to international standards, while MDR (Medical Device Regulation) is a regulatory framework specific to the European Union. ISO provides guidelines and best practices, while MDR sets legal requirements that must be met to place medical devices on the EU market.
Medical devices are classified into different risk categories based on their intended use and potential harm to patients. These categories include Class I (low risk), Class IIa and IIb (medium risk), and Class III (high risk), with higher-class devices requiring more stringent regulatory control.
There are no formal prerequisites to attend this course. However, a basic understanding of medical devices and risk management principles will be beneficial for delegates to get the most out of the training.
This course is ideal for Medical Device Manufacturers, Regulatory Professionals, Quality Assurance Personnel, and Risk Management Teams. It is also suited for individuals involved in the development, design, and post-market surveillance of medical devices.
The ISO 14971 standard is an international guideline that defines the risk management process for medical devices. It helps manufacturers identify potential risks, implement control measures, and monitor the effectiveness of these controls throughout the device's lifecycle.
The purpose of ISO 14971 is to provide a systematic process for managing risks related to medical devices. It ensures that all risks are identified, evaluated, and controlled to protect patient safety and comply with regulatory requirements.
In this course, you will learn how to implement an effective risk management process, assess potential hazards, evaluate risk acceptability, and apply risk control measures in line with ISO 14971 requirements. You will also explore post-market surveillance and reporting.
This certification aims to provide professionals with the knowledge and skills to effectively manage risks associated with medical devices. It ensures compliance with global standards, contributing to improved device safety and regulatory success.
This training helps organisations minimise risks, ensure product safety, and meet regulatory requirements. Delegates will gain practical skills in risk management, leading to better decision-making and reduced liability for medical device manufacturers.
The course is designed to be accessible to professionals at various levels, from beginners to those with intermediate knowledge of medical devices. Prior experience with risk management or medical devices will be helpful but is not required.
Holding this certification demonstrates your expertise in managing risks in line with ISO 14971, which is essential for ensuring the safety and effectiveness of medical devices. It also showcases your commitment to regulatory compliance, making you an asset to any medical device organisation.
The course includes comprehensive materials, practical exercises, and expert-led sessions covering the ISO 14971 standard, risk assessment techniques, and real-world case studies. You will also receive certification upon successful completion.
This training is valuable for professionals involved in quality assurance, regulatory affairs, risk management, product development, and post-market activities for medical devices. It is especially relevant for those aiming to ensure compliance with international standards.
The duration of this ISO 14971 Risk Management for Medical Devices Course is 1 day.
Yes, The Knowledge Academy offers customised corporate training solutions for ISO 14971 Risk Management for Medical Devices. Our training can be tailored to meet the specific needs of your organisation, ensuring comprehensive risk management education for your team.
This training is essential for professionals looking to enhance their knowledge of risk management in the medical device industry. It ensures compliance with international standards, enhances product safety, and supports successful regulatory approvals.
Yes, we offer 24/7 support to our delegates to ensure they can access help whenever needed. Our dedicated team is always available to assist with any queries or issues related to the course.
After completing this course, you will be equipped to implement effective risk management processes within your organisation. You can apply your new skills to improve the safety of medical devices and ensure compliance with ISO 14971.
Yes, The Knowledge Academy offers a self-paced version of the ISO 14971 Risk Management for Medical Devices Course, allowing you to learn at your own pace and convenience while still benefiting from comprehensive training materials.
If you are unable to access the course, please contact our customer support team, who are available 24/7 to assist with any technical or registration related issues.
This certification opens doors to various roles in the Medical Device Industry, including positions in Regulatory Affairs, Quality Assurance, Risk Management, and Product Development. It is particularly valuable for professionals involved in compliance and safety management.
Yes, there is an assessment at the end of the training to validate your understanding of ISO 14971 principles and risk management techniques. Successful delegates will receive a certificate upon completion.
What is the cost/training fees for ISO 14971 Risk Management for Medical Devices Training in Canada?
The training fees for ISO 14971 Risk Management for Medical Devices Trainingin Canada 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 Canada
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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"
Joshua Davies, Thames Water
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