Questions on Training Procedure and Procedure for Infrastructure and Work Environment
1. The reason of my mail is to ask you on which document of the toolkit can I find the one that describes the trainings product?
2. On the Procedure for Infrastructure and Work Enviroment document, on section 3.5 (Monitoring and measuring environmental conditios) I wonder if this section is necessary environmental conditions nor a cleanroom to do the device, the device is not invasive and it's mostly a software with sensors to check basic vital signs using IoT. Thank you very much for your help and I'll be
waiting for your answers.
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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
1. The reason of my mail is to ask you on which document of the toolkit can I find the one that describes the trainings product?
In the folder 04_Procedure_for_Human_Resources are all the necessary elements for education and training.
2. On the Procedure for Infrastructure and Work Enviroment document, on section 3.5 (Monitoring and measuring environmental conditios) I wonder if this section is necessary environmental conditions nor a cleanroom to do the device, the device is not invasive and it's mostly a software with sensors to check basic vital signs using IoT.
In that case, one condition that you need to monitor is if you have a server room because it is not allowed to be too hot in the server room. The other one is for the sensors that you are mentioning - do they need to be stored before implementation to your software at a certain temperature?
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May 24, 2023