Medical Devices Quality Management System - ISO 13485:2016 (Udemy.com)

Well delivered so far

Sehr detailliert Learn Material. Ich bin voll sicher mehr und verständlich über IOS13485:2016 zu wissen.

I enjoyed this insightful introduction to ISO13485:2016. The content was well-organized and provided a clear general overview of Medical Devices QMS. The course was a valuable experience.

The course very lightly reviewed the requirements of the standard, glossing over much of the ISO 13485 requirements. This course alone is insufficient to start the implementation of ISO 13485. The course could benefit from longer discussions on the requirements of each clause.

The course content was exactly as described, the presenter was clear and the bonus material helpful.

Helped to break down the standard in a digestable way. I am satisfied!

Der Kurs gibt einen guten Überblick, ist aber sehr theoretisch. Der Kurs könnte die Theorie durch Beispiel anschaulicher machen und zudem darauf eingehen, wie dies in der Praxis umgesetzt wird.

Gave me more of an understanding of the projects I had done between undergraduate school and graduate school.

It’s a wonderful course designed with detailed information for the ISO 13485 standard clauses. Very well executed and content of the course is detailed as well. It matched my expectation to understand the ISO 13485:2016 standard.Thank you:)

This course gives your what ISO 13485:2016 requirements mean. For someone who has some background on QMS would easily understand. Since I have a background on ISO 9001:2015, it was easy for me to understand. I have a few recommendations: 1. Its better to first state what the actual clause of ISO 13485:2016 states in the official ISO document. 2. Then explain what does the actually mean. This is because for someone who does not have any QMS background would find it very easy to understand. But still, for anyone who wants to get an overview of ISO 13485:2016, I would recommend this course.