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
Company’s Keywords:
medical device, ivd development, regulatory strategy & implementation, ce marking, international registrations, compilation & maintenance technical documentation, quality management systems according iso 13485, qsr, auditing, risk management according iso 14971, usability, biocompatibility, clinical evaluation, post market surveillance due diligence, data science & analytics, market access, notified body communication
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