ISO 14971 Risk Management For Medical Devices Training - United States

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

Attending this 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 outlines Risk Management principles specific to medical devices, ensuring their safety and efficacy throughout their lifecycle. Its relevance lies in minimising potential hazards, ensuring patient safety, and complying with regulatory requirements in developing and maintaining medical devices.

Proficiency in ISO 14971 is crucial for Medical Device Manufacturers, Regulatory Affairs Professionals, and Quality Assurance Experts. Mastery of this standard enables them to establish robust risk management processes, assess and mitigate risks associated with medical devices, and ensure compliance with regulatory standards, which is critical for delivering safe and effective medical devices to the market.

This 1-day Training immerses delegates in ISO 14971's principles, covering risk management methodologies, hazard analysis, and risk assessment techniques specific to medical devices. Delegates gain insights into implementing effective risk management strategies, ensuring device safety, and complying with regulatory standards, empowering them to navigate complex risk scenarios in medical device development.

Course Objectives

• To implement robust risk management processes in medical device development
• To assess and mitigate risks associated with medical devices
• To ensure compliance with regulatory standards in device development
• To enhance patient safety through effective risk management strategies
• To navigate complex risk scenarios in medical device development

Delegates completing this ISO Certification Course will possess comprehensive expertise in ISO 14971, enabling them to implement robust risk management processes specific to medical devices. They'll also be equipped to assess, mitigate, and manage risks effectively.

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