Course Name
Training and Workshop of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (2 days)
Course Overview
Welcome to the Training and Workshop of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices. This comprehensive course delivers in-depth knowledge on the requirements, terminology, principles, and processes required for the risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The processes described in this program intend to assist manufacturers of medical devices in identifying the hazards associated with the medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of those controls.
Course Objective
At the end of the presentation, participants should be able to achieve the following session and terminal objectives:
● Understand the philosophy and principles of the application of risk management to medical devices.
● Be aware of the methods and requirements related to a risk management system, specifically covering risk analysis, risk evaluation, risk control, overall residual risk, risk management review, and production and post-production activities.
● Understand the key factors for risk management for medical device development.
● Become an expert in the knowledge of the requirements, terminology, principles, and processes for the risk management of medical devices.
Course Benefits
Participating in this training and workshop provides organizations and individuals with several key advantages:
● Equips participants with the practical expertise needed to effectively identify hazards, estimate risks, and monitor risk control effectiveness.
● Develops highly competent and qualified company personnel capable of implementing and applying the risk management process to all phases of the life cycle of a medical device within the certification scope.
● Provides hands-on experience through a comprehensive group workshop focused on risk analysis evaluation based on ISO 14971:2019.
● Supplies participants with valuable reference handouts detailing international standard guidelines (ISO/EN).
Who Must Attend
This training is designed for company personnel who need to be highly competent and qualified in implementing and applying the risk management process to all phases of the life cycle of a medical device within the certification scope.
Methodology
The course is delivered using an interactive lesson plan that combines expert instruction with active participant practice:
● Set the Stage: The training begins with an ice breaker titled “Recognizing and Identifying the important of risk management system for medical device,” followed by a welcome, introduction, and agenda overview.
● Facilitator Instruction: The facilitator illustrates the overview of the risk management system using PowerPoint presentations, flip charts, and handouts.
● Interactive Practice: Participants are asked to write down what they know about risk management systems and are encouraged to ask clarifying questions regarding the topics.
● Comprehensive Workshop: Participants engage in a group workshop focused on risk analysis evaluation, where they must collaborate and participate in a group presentation.
● Review and Transfer: The session concludes with a summarized review of the whole presentation and the distribution of reference handouts covering international standard guidelines (i.e., ISO/EN).
Course Duration
● The duration of this training and workshop program is 2 days.
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