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.

Technologies
Outlook MailChimp SPF Microsoft Office 365 Google Analytics Gravity Forms Apache Google Font API reCAPTCHA Bootstrap Framework WordPress.org Mobile Friendly Data Analytics
Keywords
iso 13485 implementation regulatory affairs medical device certification services device registration eu conformity procedures device classification vigilance system iso 13485 quality system implementation consultancy b2b device technical file medical devices eu mdr regulatory strategy technical documentation medical device standards eu regulatory updates eu mdr transition support healthcare quality management system eu medical device regulation (mdr) consultancy notified body support eu notified bodies eu mdr vigilance system regulatory documentation imdrf toc eu compliance eu legislation updates post-market surveillance
Company Information
  • Employees 10
  • Founded 1998
Location

13 Esdoornlaan, Maarn, Utrecht, Netherlands, 3951

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