CEplus is an international regulatory service provider for medical devices and in vitro diagnostics, based in Badenweiler, in the immediate vicinity of Freiburg/Germany and Basel/Swiss. CEplus was founded in 2009 starting with profound operational experience in medical device and IVD industry as well as Notified Body business. With our dynamic “hands-on-mentality”, the service of CEplus extends far beyond traditional consulting.

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. We accompany you as a competent partner during implementation of the general safety and performance requirements in the context of CE-marking for medical devices, in-vitro diagnostics as well as active implantable medical devices. Additionally we can support and advice you as well as coordinate required activities in more specific fields like clinical evaluations or the choice and implementation of conformity assessment routes. Our long experience with, as well as at Notified Bodies will benefit you during the required establishment of systems for risk- and quality management.

In addition, we provide support for international registrations. 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.

To drive our client´s success, the key elements of our business philosophy are:

  • Profound praxis-oriented knowledge in regulatory affairs of medical devices and IVD
  • Maintaining a network to handle complex projects for specific client needs
  • Trustworthy communication with notified bodies and authorities which streamlines the process for product registration

For further information see our Service portfolio.