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Any thoughts on a plan to get CE marked products from a one person company?
It is about a one person Dutch company who wants to sell medical devices under their own name (brand label). The OEM company in the UK holds an ISO 13485 certificate, a Full Quality Assurance certificate accoriding MDD Annex II, section 3.2 and a Design examination certificate according to MDD Annex II, section 4 for these products.
Has anyone experience with such constructions? What would you advise? I guess that there should be a technical / quality agreement between the private label company and the original manufacturer. Has anyone some examples of such contratcs?
Any help is appreciated.
Rob Udo
It is about a one person Dutch company who wants to sell medical devices under their own name (brand label). The OEM company in the UK holds an ISO 13485 certificate, a Full Quality Assurance certificate accoriding MDD Annex II, section 3.2 and a Design examination certificate according to MDD Annex II, section 4 for these products.
Has anyone experience with such constructions? What would you advise? I guess that there should be a technical / quality agreement between the private label company and the original manufacturer. Has anyone some examples of such contratcs?
Any help is appreciated.
Rob Udo
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