CE Plus GmbH
Country headquarter:
Germany.
Market presence:
EU, US and 90 countries worldwide (regulanet network).
General description:
CEplus 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 conformity assessment or another form of 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.
Areas of regulatory/reimbursement support:
We support clients to meet the requirements for CE-marking for - Medical Devices - In Vitro Diagnostics - Active Implantable Devices - Medical Software / Apps - Combination Products (Drug/Medical Device) - Companion Diagnostics.
https://ec.europa.eu/digital-single-market/en/ehealth-and-ageing
The eHealth Hub project has received funding from the European Union’s Horizon 2020
Research and Innovation Programme under Grant Agreement No727683.