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Tag: "MDR" - Expert Advice Community



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  • Distributors role in UK MDR changes


    Would anyone have any upto date information documents on the role of distributors in UK MDD/ MDR.  With the changes of the MHRA now extending the deadline also, some of my customers and sub distributors are asking me questions that I don't have answers to, becasue as far as I was aware I can't see any changes that imapct distributors.



  • MDR vs CFR 21

     “Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”  

    Gap analysis MDR vs CFR 21