Course Category: Risk Management

Training and Workshop of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (2 days)

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 […]

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Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (1 day)

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 […]

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