ISO 13485 & EU MDR / Specific requirement to provide After-Sales Service
I was wondering, according to MDSAP/ISO 13485 or Health Canada regulation, is there any specific requirement to provide After-Sales Service or spare parts for specific time (such as 10 years /20 years)?
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No, there is no such direct requirement according to ISO 13485 and MDSAP. Considering the Health Canada regulation, I really do not have information regarding that regulation.
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