ISO 13485 & EU MDR / 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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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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