| File Name: | Overview – Medical Devices (ISO 14971:2019) |
| Content Source: | https://www.udemy.com/course/overview-medical-devices-iso-149712019/ |
| Genre / Category: | Other Tutorials |
| File Size : | 1.6 GB |
| Publisher: | Alexander Walter |
| Updated and Published: | February 20, 2026 |
This online video course offers a comprehensive yet accessible introduction to the ISO 14971 standard, the internationally recognized guideline for risk management of medical devices. The course is specifically designed for beginners who have little or no prior experience with ISO 14971 and who are looking for a clear, structured overview rather than in-depth technical training.
Throughout the course, learners will gain an understanding of the purpose and background of ISO 14971 and its role in ensuring the safety of medical devices throughout the entire product lifecycle. The course explains how ISO 14971 fits into the broader medical device regulatory environment and how it supports compliance with regulatory expectations worldwide. Key concepts such as hazard identification, risk analysis, risk evaluation, risk control, residual risk assessment, and the overall risk management process are introduced in a clear and practical manner.
The course focuses on explaining what ISO 14971 requires and why these requirements exist, rather than how to implement them within a specific company process. Detailed procedural implementation and company-specific documentation approaches are intentionally kept at a high level to ensure the content remains accessible to newcomers.
By the end of the course, participants will be familiar with essential ISO 14971 terminology and principles and will understand the expectations placed on development teams working on regulated medical device products. This foundational knowledge will help learners communicate more effectively with engineering, quality, and regulatory professionals and will prepare them for further, more advanced training on medical device risk management.
This course is ideal for engineers entering the medical device domain, project managers, quality and regulatory professionals, and anyone seeking a solid introductory overview of the ISO 14971 standard.
DOWNLOAD LINK: Overview – Medical Devices (ISO 14971:2019)
Overview_Medical_Devices_ISO_14971_2019_.part1.rar – 1000.0 MB
Overview_Medical_Devices_ISO_14971_2019_.part2.rar – 699.3 MB
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