ISO 14971 Training
Our training program covers ISO 14971:2019 which outlines a framework for applying risk management to medical devices. It emphasizes identifying, evaluating, and controlling risks throughout a device's lifecycle, ensuring patient safety. The standard guides manufacturers in making informed decisions, balancing benefits and risks, and complying with regulatory requirements to enhance healthcare outcomes.
Course Objectives
At the end of the presentation participants should be able to do the following:
• An expert with knowledge of the requirements, terminology, principles, and 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, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.
• Highly competent and qualified company personnel in implementing and applying risk management processes to all phases of the life cycle of a medical device within the certification scope.
Course Outline
Set the State- Overview:
• Ice breaker- Recognizing and Identifying the importance of risk management systems for medical devices.
• Objectives of the workshop
• Agenda
• Administrative arrangement
Session 1: Overview of Risk Management System for Medical Device
• Introduction of ISO 14971:2019
• Overview of ISO 14971 and
• Briefing on each clause of ISO 14971:2019