Valicare TheraBionics

TheraBionic GmbH, a German/American company, has recently received CE mark for their medical device, THBC P1. We are pleased about the success of our customer and thank them for the past cooperation in a joint project.

TheraBionic (http://therabionic.com) is the developer and manufacturer of THBC P1, a medical device of class IIa. It is a battery-operated high-frequency generator which is used in tumour therapy.

Employees of Valicare GmbH supported Therabionic in preparing the development documentation for this medical device. The creation of development documentation as part of the design dossier is a requirement of EN ISO13485:2016 in the context of the development of medical devices and a prerequisite for obtaining CE mark. The certification was carried out in accordance with Annex II of Directive 93/42/EEC.