TERMINAL OBJECTIVES
After this presentation, participants are expected to become:
- An expert as the knowledge in the requirements, terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
- Highly competent and qualified Company’s personnel in implementing and applying risk management process to all phases of the life cycle of a medical device within the certification scope.
SESSION OBJECTIVES
At the end of the presentation participants should be able to do the following:
- Understand the philosophy and principles of application of risk management to medical device.
- Aware of method and requirement related to risk management system – risk analysis, risk evaluation, risk control, overall residual risk, risk management review, production and post-production activities.
- Understand the key factors for risk management for medical device development.
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