CE plus

medical devices

About

CE plus is an international service provider for medical devices and in-vitro diagnostics, based in Badenweiler, in the immediate vicinity of Freiburg and Basel. Our core competence is CE-marking for the European market. Whether undergoing a CE marking process or other international registration procedure, you will need a number of satellite activities in order to meet all needed requirements, e.g. extensive quality and risk management systems. We offer a broad range of activities in order to realize your market success. In doing so resources of our international network will be coordinated in a way that provides you access to the know-how needed for your project. Interdisciplinary teams develop project specific solutions which will lead to outstanding market success. For more information please visit: https://www.ceplus.eu Legal Notice: https://www.regenold.com/impressum.html

Technologies

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Keywords

market access post market surveillance due diligence biocompatibility quality management systems according iso 13485 qsr international registrations auditing compilation & maintenance technical documentation medical device ivd development regulatory strategy & implementation clinical evaluation risk management according iso 14971 data science & analytics notified body communication ce marking usability medical equipment manufacturing post-market surveillance testing laboratories and services quality management system clinical evaluation reports system certification regulatory network safety and performance risk assessment product registration medical devices international registration regulatory services risk management mdr/ivdr compliance

Location

4 Zoellinplatz, Badenweiler, Baden-Wuerttemberg, Germany, 79410

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