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Is ISO 13485 certification applicable for company which provides eQMS dedicated to medical device industry clients?

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Guest user Created:   Nov 01, 2022 Last commented:   Nov 02, 2022

Is ISO 13485 certification applicable for company which provides eQMS dedicated to medical device industry clients?

I'd like to know if ISO 13485 certification is applicable for our company which provides an eQMS dedicated to the medical device industry clients, though our eQMS is not a medical device

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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.

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Kristina Zvonar Brkić Nov 02, 2022

If you provide eQMS it is not necessary to have implemented ISO 13485. Rather to me, it seems that it would be helpful to have ISO 9001 and/or ISO 27001. 

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Nov 01, 2022

Nov 02, 2022