What is ISO 13485 for medical devices?

A brief introduction to this ISO Standard for medical devices. ISO 13485:2016

[mubafaw]

Brilliant! Straight to the point, concise yet very informative. Thank you! 😊👍

[bellesmith]

Excellent consolidation of information. Concise yet thorough. Thank you!

[kishin]

Thanks for the brief overview, Terry! I am on a journey to develop system elements and found this refresher quite helpful to further solidify my understanding of the standards.

[marcochimio]

Wonderful review of the clauses. Thank you.

[HappySingh-lguk]

Please share the link to download iso Standards

[shohelahmed]

i want to get a ISO 13485 certificate. so what type of documents i need to create. pls send sample of that draft copy of them.

[NatarajanBalan]

Looks like this standard has not been revised with ISO 9001:2015 with the 10 clause structure

[kennekam]

To what extent is ISO 13485:2016 applicable to distributors of medical devices. They import devices and sell them locally as is.

[jask]

Can the manufacturer hold ISO 13485 without 9001 or it has to get 9001 first or they come together? How does it work? Thanks

[maryammirjafari]

Hi Terry

Thanks for your video
I have a question and would like to get your opinion please.
I would like to implement iso13485:2016 for the hospital biomedical engineering dept.
What do you think
Thanks

[wahidnawaz]

very good. I want to ask what is the difference between iso13485 and the medical device/IVD regulation. Why do you need both.

[kennekam]

I see you live in Canada, but sound like a South African :)