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What is the primary purpose of a Quality Management System in medical devices?
What is the primary purpose of a Quality Management System in medical devices?
Which of the following standards is related to Risk Management for Medical Devices?
Which of the following standards is related to Risk Management for Medical Devices?
What is the correct classification of implantable devices according to the European Classification and Risk Class?
What is the correct classification of implantable devices according to the European Classification and Risk Class?
Which stage of the risk management process involves prioritizing mitigation efforts based on the level of risk?
Which stage of the risk management process involves prioritizing mitigation efforts based on the level of risk?
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What is the primary goal of risk management in medical devices?
What is the primary goal of risk management in medical devices?
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Which of the following is NOT a stage of the risk management process?
Which of the following is NOT a stage of the risk management process?
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What is the purpose of EN ISO 13485:2016?
What is the purpose of EN ISO 13485:2016?
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Which of the following medical devices is classified as low-moderate risk?
Which of the following medical devices is classified as low-moderate risk?
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What is the purpose of continuously monitoring and updating the risk management process?
What is the purpose of continuously monitoring and updating the risk management process?
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Study Notes
European Classification and Risk Class
- Medical devices are classified into four risk classes based on the level of risk associated with their use:
- Class I: Low risk, e.g., bandages, examination gloves
- Class IIa: Low-moderate risk, e.g., contact lenses, hearing aids
- Class IIb: Moderate-high risk, e.g., ventilators, infusion pumps
- Class III: High risk, e.g., implantable devices, pacemakers
Standards
- Medical devices must comply with relevant harmonized standards, such as:
- EN ISO 13485:2016 (Quality Management System for Medical Devices)
- EN ISO 14971:2012 (Risk Management for Medical Devices)
- EN 62304:2006 (Software Life-Cycle Processes for Medical Devices)
Quality Management System (QMS)
- A QMS is a set of policies, procedures, and processes to ensure the quality of medical devices:
- Includes design, development, production, installation, and servicing
- Ensures compliance with regulatory requirements and standards
- Continuously monitors and improves the quality of medical devices
Risk Management
- Risk management is a systematic process to identify, evaluate, and mitigate risks associated with medical devices:
- Risk analysis: Identify potential hazards and estimate their risk
- Risk evaluation: Determine the level of risk and prioritize mitigation efforts
- Risk control: Implement measures to mitigate or eliminate risks
- Risk monitoring: Continuously monitor and update the risk management process
- Risk review: Periodically review the risk management process to ensure its effectiveness
European Classification and Risk Class
- Medical devices are classified into four risk classes based on the level of risk associated with their use
- Class I: Low risk, includes devices such as bandages and examination gloves
- Class IIa: Low-moderate risk, includes devices such as contact lenses and hearing aids
- Class IIb: Moderate-high risk, includes devices such as ventilators and infusion pumps
- Class III: High risk, includes devices such as implantable devices and pacemakers
Standards
- Medical devices must comply with relevant harmonized standards
- Examples of harmonized standards include EN ISO 13485:2016, EN ISO 14971:2012, and EN 62304:2006
- EN ISO 13485:2016 sets out requirements for a Quality Management System (QMS) for medical devices
- EN ISO 14971:2012 sets out requirements for risk management for medical devices
- EN 62304:2006 sets out requirements for software life-cycle processes for medical devices
Quality Management System (QMS)
- A QMS is a set of policies, procedures, and processes to ensure the quality of medical devices
- A QMS includes design, development, production, installation, and servicing
- A QMS ensures compliance with regulatory requirements and standards
- A QMS continuously monitors and improves the quality of medical devices
Risk Management
- Risk management is a systematic process to identify, evaluate, and mitigate risks associated with medical devices
- Risk management involves risk analysis, risk evaluation, risk control, risk monitoring, and risk review
- Risk analysis identifies potential hazards and estimates their risk
- Risk evaluation determines the level of risk and prioritizes mitigation efforts
- Risk control implements measures to mitigate or eliminate risks
- Risk monitoring continuously monitors and updates the risk management process
- Risk review periodically reviews the risk management process to ensure its effectiveness
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Description
This quiz covers the classification of medical devices into four risk classes based on the level of risk associated with their use, and the relevant standards they must comply with.
