CE plus is a division of regenold GmbH - an international regulatory service provider specialized in pharmaceuticals, medical devices, cosmetics, food supplements and other products. Due to close cooperation with experts within regenold GmbH, we are able to offer a wide range of regulatory services. The core activities of CE plus are regulatory services for medical devices and in vitro diagnostics. CE plus is based in Badenweiler, in the immediate vicinity of Freiburg/Germany and Basel/Switzerland. In 2009 CE plus was founded as a separate company within the Regenold Group by a team who had extensive operational experience in the medical device and IVD industry and Notified Bodies; in July 2021 it was integrated into regenold GmbH. With our dynamic “hands-on-mentality”, the service of CE plus 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, advise you and coordinate required activities in more specific fields like clinical evaluations or the choice and implementation of conformity assessment routes. Our extensive experience in industry and Notified Bodies will benefit you during the required establishment of systems for risk- and quality management.

In addition, we provide support for international registrations. We do this by using the resources of our international network, which we will coordinate, to provide you with 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.