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Drug-device combination product development and manufacturing

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Guest user Created:   Jun 12, 2023 Last commented:   Jun 12, 2023

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jun 12, 2023

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

Jun 12, 2023