Course Objectives
At the end of the program participants should:
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Aquire knowledge of the requirements, terminology, principles, and process for risk management of medical devices.
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Understand the risk management for software as a medical device and in vitro diagnostic medical devices.
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Able to assist in identifying the hazards associated with the medical device.
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Able to estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.
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Be a highly competent and qualified company personnel in implementing and applying risk management.
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Course Outline
UNIT 1: Overview
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Recognizing and identifying the importance of risk management systems for medical devices
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Administrative arrangement
UNIT 2: Overview of Risk Management System for Medical Device
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Introduction of ISO 14971:2019
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Overview of ISO 14971
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A deeper dive into each clause
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Target Audience
Quality Personnel, QA/QC Lab technician, and QA/QC Executive
Duration
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1 full-day courses
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Physical Training (On-site); or
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Online Training​
Advancement trough training
We provide:
Diverse learning methods:​
classroom-based, virtual, and blended courses
Industry-specific solutions:
tailored training for medical device manufacturers and sterilizers
Customized learning:
bespoke training solutions based on industry needs
Standard-based training:
comprehensive ISO and other standard-specific courses
Specialized subject training:
covering microbiology techniques and validation of test methods
Industry-experienced trainers:
expert trainers with years of experience in the industry
ISO 14971 Training
Application of Risk Management in Medical Devices
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Requirements, terminology, principles, and process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
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Assist manufacturers to identify hazards associated with the medical device.
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Estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.
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Competency and qualification of personnel in implementing and applying risk management processes.
