Udemy - Overview - Medical Devices (ISO 14971 - 2019) torrent

Overview - Medical Devices (ISO 14971:2019)

https://WebToolTip.com

Published 2/2026
Created by Alexander Walter
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Level: All Levels | Genre: eLearning | Language: English | Duration: 41 Lectures ( 2h 17m ) | Size: 1.66 GB

Medical devices — Application of risk management to medical devices

What you'll learn
✓ Explain the purpose, scope, and regulatory relevance of ISO 14971 for medical device risk management.
✓ Describe the structure and key elements of the risk management process defined in ISO 14971.
✓ Identify hazards, hazardous situations, and potential harms associated with medical devices.
✓ Understand the principles of risk analysis, risk evaluation, and risk control.
✓ Explain how risk acceptability is determined and documented within a risk management framework.
✓ Understand the concept of residual risk and the evaluation of overall residual risk.
✓ Describe the role of risk management throughout the product lifecycle, including production and post-production activities.
✓ Recognize how ISO 14971 supports communication between engineering, quality, clinical, and regulatory teams.

Requirements
● No prior knowledge required