ISO 13485 & EU MDR / Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards
I am trying to cross map ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards that apply to medical testing labs that develop IVTs. In development of a QMS that will satisfy all of them. Any advice?
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It is really hard work, but I think it is doable. Since both standards are similar to ISO 9001:2008, maybe that is the starting point.
Following articles can be helpful:
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