Human Resources Training
The reason of my message is to ask you something about the Human Resources Procedure and Trainings. The thing is that we develop a product and then we give trainings to doctors so they can use it. So my question is: ¿where should we include this training information? Because doctors are not employees of the company, they are users of the product, my question came in while filling the Procedure for Human Resources appendx.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
This training is covered by the 7.2.1 Determination of requirements related to the product. In point d) you have - any user training needed to ensure specified performance and safe use of the medical device.
Hello Kristina, and where can I find this clause implemented on the toolkit? Thank you very much!
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May 11, 2023