ISO 14971 Risk Management in Medical Devices Training

PURPOSE: EN ISO 14971 Risk Management in Medical Devices Training helps define, assess, control risks in the life cycle of a product in medical devices and implement a risk management framework within the framework of continuous compliance. This standard covers the process aimed at predicting, evaluating, controlling the risks related to the devices and monitoring the efficiency of these controls in order to define the dangers accompanied by medical devices including in vitro diagnostic medical devices. 

PARTICIPANT PROFILE: Especially producers, distributors and dealership employees related to medical devices due to the range of stakeholders including risk management concepts, medical doctors, institutions and corporations providing health services, industry, patients and citizens. 

CONTENT OF TRAINING:

• Scope 
• Terms and Definitions 
• General Conditions for Risk Management 
• Risk analysis 
• Risk evaluation 
• Risk control 
• Evaluation of total residual risk acceptability 
• Risk management report 
• Production and post-production information 
• Reasons for the conditions 
• Review of the risk management process for medical devices 
• Questions used to define the characteristics of medical devices that affect safety 
• Risk concepts applied to medical devices
• Examples for dangers, predictable results of events and dangerous situations 
• Risk management plan 
• Information on risk management techniques 
• Guide on risk management for in vitro diagnostic medical devices 
• Guide on risk analysis process for biological dangers 
• Safety information and information on residual risk