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  • Hi I completely agree with Richard´s interpretation. BR Evangelos CE marking auditor/ ISO auditor ------------------------------ Evangelos Tavandzis Praha Czech Republic ------------------------------

  • Hello, I am a Regulatory Affairs Specialist in medical devices for the last five years and I have just recently started studying for the RAC US, any advice on how to approach this? I have recently worked with RAPS to set up Ireland's Local Netwroking Group, any suggestions for running a study group? Thank you! ------------------------------ Maria ...

  • ​If you are referring to a domestic distributor that is furthering your device within the USA, I don't know of any requirement for an agreement.  The distributor has requirements, but I don't believe that those are specifically bound to you.  The manufacturer has to "maintain records of the name and address of the initial consignee."  Your distributor ...

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