China's Best One-Stop Medical Equipment Provider
About

CEpartner4U serves as consultant and Authorized Representative (AR or EC Rep) under the European medical device regulations for hundreds of manufacturers from all over the world. From longstanding experience, we understand the dynamics of CE marking. As Authorized Representative, we consider it our privilege and duty to monitor your regulatory position in Europe. In our capacity, we advise manufacturers, importers, distributors and other stakeholders about the interpretation and application of the European regulations for medical devices. We serve an important customer base with classified content. Our IT supplier is ISO27001:2017 certified and is up to date with the latest developments in the security space. CEpartner4U understands that security measures are key for a safe workspace and has developed a stringent IT policy to that effect. Founded in 1998, CEpartner4U has matured to a well-known and respected organization. CEpartner4U is staffed with a team of experienced lead assessors and medical device researchers. CEpartner4U has a branch office in the UK, UKCApartner4U, providing UK Responsible Person services. Apart from that, we offer Swiss Representative services.

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Keywords
iso 13485 implementationregulatory affairsmedical device certificationservicesdevice registrationeu conformity proceduresdevice classificationvigilance systemiso 13485quality system implementationconsultancyb2bdevice technical filemedical deviceseu mdr regulatory strategytechnical documentationmedical device standardseu regulatory updateseu mdr transition supporthealthcarequality management systemeu medical device regulation (mdr) consultancynotified body supporteu notified bodieseu mdr vigilance systemregulatory documentationimdrf toceu complianceeu legislation updatespost-market surveillance
Company Information
  • Employees10
  • Founded1998
Location

13 Esdoornlaan, Maarn, Utrecht, Netherlands, 3951

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