ISO 14971 Risk Management For Medical Devices Training - Belgium

Who should attend this ISO 14971 Risk Management for Medical Devices Training Course?

Attending ISO 14971 Risk Management for Medical Devices Training Course can provide attendees with comprehensive insights into Risk Management processes, methodologies, and best practices within the medical device industry. Here are the individuals who might benefit from attending an ISO 14971 Risk Management for Medical Devices Training Course:

• Medical Device Manufacturers
• Quality Control Professionals
• Regulatory Affairs Professionals
• Risk Management Professionals
• Clinical Research Professionals
• Validation and Verification Engineers
• Biomedical Engineers
• Legal and Compliance Professionals

Prerequisites of the ISO 14971 Risk Management for Medical Devices Training Course

There are no formal prerequisites for attending this ISO 14971 Risk Management for Medical Devices Training Course.

ISO 14971 Risk Management for Medical Devices Training​ Course Overview

ISO 14971:2019 defines the international requirements of risk management systems for medical devices, including best practices and the entire lifecycle of a medical device. The ISO 14971 standard aims to help manufacturers identify, estimate, evaluate, monitor, and control risks associated with a medical device. ISO 14971 helps organisations to minimise risk by checking whether the control measures were implemented correctly. This ISO 14971 Risk Management for Medical Devices training will allow medical device professionals to successfully improve their business and risk management efforts. Obtaining this training will help individuals to excel in highly reputed jobs and upgraded salaries.

This 1-day ISO 14971 Risk Management for Medical Devices training course provides delegates with a deep understanding of ISO 14971 medical devices concepts. During this training, delegates will learn various concepts such as introduction to ISO 14971, general requirements for risk management, risk management process, management responsibilities, risk analysis process, identification of hazards, risk control, etc. Our highly skilled and professional trainer who has years of experience teaching ISO courses will conduct this training.

They will also cover the following essential concepts such as:

• Risk management process
• Terms and definitions
• Identification of hazards
• Post-production information
• Risk management report
• Qualification of personnel

At the end of this training course, delegates will be able to successfully implement a risk management system within an organisation. They will also be able to estimate the risk(s) for each hazardous situation efficiently.

What’s included in this ISO 14971 Risk Management for Medical Devices Training Course?

• World-Class Training Sessions from Experienced Instructors
• ISO 14971 Risk Management for Medical Devices Training Certificate
• Digital Delegate Pack

ISO 14971 Risk Management for Medical Devices Exam Information 

To achieve the ISO 14971 Risk Management for Medical Devices Training, candidates will need to sit for an examination. The exam format is as follows:  

• Question Type: Multiple Choice  
• Total Questions: 30  
• Total Marks: 30 Marks  
• Pass Mark: 50%, or 15/30 Marks  
• Duration: 40 Minutes