Drug-device combination product development and manufacturing
My main question is what is the regulation or what level of ISO 13485 should be compliance for Drug-device combination product development and manufacturing, ie the pen-injector or auto-injector for insulin or other drug?
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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
Each manufacturer of medical devices must be in compliance with ISO 13485 no matter the type and class of medical device. But, since MDR 2017/745 has additional requirements for quality management system, please look into the ISO 13485:2016/A11:2021.
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Jun 12, 2023