Course Name
Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (1 day)
Course Overview
Welcome to the Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices. This comprehensive one-day course is designed to provide participants with expert knowledge of the requirements, terminology, and principles of risk management for medical devices.
The process detailed in this course intends to assist manufacturers in identifying hazards associated with medical devices (including software as a medical device and in vitro diagnostic medical devices), estimating and evaluating associated risks, controlling these risks, and monitoring the ongoing effectiveness of those controls.
Course Objective
By the end of this presentation, participants will be able to achieve the following terminal and session objectives:
● Understand the core philosophy and principles of applying risk management to medical devices.
● Become aware of the methods and requirements related to a risk management system, including risk analysis, risk evaluation, risk control, overall residual risk, risk management review, and production/post-production activities.
● Understand the key factors essential for risk management during medical device development.
● Become highly competent and qualified company personnel capable of implementing and applying the risk management process across all phases of a medical device’s life cycle within the certification scope.
Course Benefits
Participating in this training provides significant professional and organizational benefits:
● Equips personnel with the expertise needed to systematically identify, evaluate, and control hazards associated with medical devices.
● Ensures your team is highly competent in applying risk management processes throughout the entire life cycle of a medical device.
● Provides a structured understanding of complex concepts, including overall residual risk and post-production activities, ensuring robust regulatory compliance.
● Includes comprehensive handouts and references to international standards (ISO/EN) for ongoing guidance.
Who Must Attend
This training is ideal for company personnel involved in the life cycle of a medical device who need to be highly competent and qualified in implementing and applying risk management processes. This includes professionals working with standard medical devices, software as a medical device, and in vitro diagnostic medical devices.
Methodology
The course is delivered using an interactive, facilitator-led methodology designed to maximize participant engagement and knowledge transfer:
● Set the Stage: Begins with an icebreaker focused on recognizing and identifying the importance of risk management systems, followed by an overview of workshop objectives and agenda.
● Instructor-Led Content: The facilitator utilizes PowerPoint presentations, flip charts, and handouts to clearly illustrate the overview of ISO 14971:2019, including a briefing on each specific clause.
● Participant Practice: Participants actively engage by writing down their existing knowledge about risk management systems and asking clarifying questions.
● Review and Transfer: The session concludes with a summarized review of the presentation and the distribution of reference handouts covering international guidelines (ISO/EN).
Course Duration
● This is a comprehensive 1-day training program.
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