News from Valicare

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Valicare GmbH supports Therabionic a German/American medical device manufacturer

TheraBionic GmbH received CE mark for THBC P1, 7th of September 2018.

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 ( 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.


Further information

Dr Claudia Papewalis is giving a GMP for ATMP training


If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".