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Britta Cyron

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Germany

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1 to 5 of 50+ total
Posted By Britta Cyron 22-Jan-2024 08:45
Found In Egroup: Regulatory Open Forum
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Anne, Sydney, Thank you for clarification! Best, ------------------------------ Britta Cyron Senior Specialist Regulatory Affairs ------------------------------
Posted By Britta Cyron 22-Jan-2024 08:40
Found In Egroup: Regulatory Open Forum
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Dear all, thank you for your insights. It has been very helpful! To address some of your questions/remarks: MAN, AR, IMP, and LH being under one QMS is well established practice in our company for a couple of years now and was successfully audited by our Notified Body. When I was talking about ...
Posted By Britta Cyron 19-Jan-2024 03:37
Found In Egroup: Regulatory Open Forum
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Hi Erik, this a very good point and we are thinking very had about it. Since I am quite new to working with a non-EU based company, might I ask you an additional question here? I looked into the MDR but did not find was I was looking for. The importer is a daughter company of the non-EU manufacturer. ...
Posted By Britta Cyron 19-Jan-2024 03:28
Found In Egroup: Regulatory Open Forum
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Excellent point Richard! Thanks for the reminder ;-) ------------------------------ Britta Cyron Senior Specialist Regulatory Affairs ------------------------------
Posted By Britta Cyron 19-Jan-2024 03:26
Found In Egroup: Regulatory Open Forum
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Dear all, we are company (MAN) outside the EU and therefore we need and have an Authorized Representative (AR) and an Importer (IMP). Additionally, we have a Logistics Hub (LH). AR and IMP are the same entity, a daughter of the MAN. LH is another daughter of the MAN. All entities share the same QM-System. ...