ISO 14971: Risk Management for Medical Devices 2024

Name: ISO 14971: Risk Management for Medical Devices 2024
Rating: 4.2 (73 reviews)

Become an expert in ISO 14971 -Risk Measurement and Risk Management for medical device.

Created byAnil Sharma Kandel

Last updated 9/2024

English

What you'll learn

Gain a deep understanding of ISO 14971 standard, including its purpose, scope, key terms, and specific requirements for a compliant RM system
Learn to apply the ISO 14971 risk management process to real medical devices. Master techniques for identifying hazard, analyzing risks, implementing controls.
Develop a comprehensive risk management plan. Learn to create a traceable risk management file to document the entire process
Master the pre-release risk management review. Collect and review information during production and post-prod, adapting and ensuring continuous improvement.

Course content

5 sections • 13 lectures • 1h 54m total length

Introduction9:30
Explore ISO 14971, a risk management standard for medical devices, and learn to identify hazards, analyze and evaluate risks, and implement controls across the device life cycle.

Types of Medical Devices Covered by ISO 149714:39
Explore how ISO 14971 guides risk management for all medical devices, including active, non-active, in vitro diagnostic medical devices, and software, with examples like bandages and surgical robots.
Lifecycle of a Medical Device8:37
ISO 14971 applies risk management to all phases of a medical device lifecycle—from design and development to disposal—identifying, analyzing, evaluating, and controlling risks to ensure patient safety and device effectiveness.
Benefits of using ISO14971 in companies6:56
Apply iso 14971 to identify and mitigate risks in the medical device life cycle, improving product safety, reducing development costs and time, ensuring regulatory compliance, and boosting patient confidence.

Overview of Stages of Risk Management Process4:17
Explore the ISO 14971 risk management process and its four stages: risk analysis, risk evaluation, risk control, and post-market surveillance, identifying hazards and applying controls.
Stage 1: Risk Analysis8:13
Stage 2 & 3 : Risk Evaluation and Risk Control17:15
Stage 4a: Risk Management Review7:48
Stage 4b: Post Production Activities7:43
Engage in post-production activities and continuous improvement by collecting and reviewing production data and feedback to reassess risk and update the risk controls and the risk management file.

Requirements

No experience or prior curriculum required

Description

Master medical device risk management with this comprehensive online course on ISO 14971:2019. This course provides a deep understanding of the standard, equipping you with the knowledge and skills to create a compliant and effective risk management system. You'll learn how to:

Understand ISO 14971: Grasp the standard's purpose, scope, key terminology, and requirements.
Apply Risk Management: Identify hazards, analyze risks, implement controls, and document the process effectively for real medical devices.
Create Essential Documents: Develop a comprehensive risk management plan and a traceable risk management file.
Review and Improve: Conduct a thorough risk management review and establish a system for continuous monitoring and improvement.
Gain the confidence: To conduct a thorough risk management review and establish a system for continuous monitoring and improvement.

Enroll today and gain the confidence to navigate the complexities of medical device risk management, ensuring the safety and effectiveness of your products.

Who this course is for:

Medical Device Professional wanting to learn about Risk Management Process used in Pharmaceuticals and Medical Device Companies

ISO 14971: Risk Management for Medical Devices 2024

What you'll learn

Explore related topics

Course content

Introduction to ISO149711 lecture • 10min

Applications and Benefits of ISO149713 lectures • 20min

Important Key Terms and Definitions1 lecture • 6min

Risk Management Process5 lectures • 45min

Create pFMEA, dFMEA and Risk Matrix from Scratch3 lectures • 34min

Requirements

Description

Who this course is for: