TherapySelect has set up a quality mangement according to DIN EN ISO 13485 (for medical devices). The quality management is applied to the entire company.


Admission, Authorization and Product-Saftey for the Chemotherapy-Resistance-Test (CTR-Test®)

Specific information

Summary:

QM-System

  • The CTR-Test® is an In-vitro-Diagnostic (IVD) referring to  §3.4 medical-product-law (MPG).

  • Despite the exclusive conduction of the test within the company, it is not an in-house IVD in accordance with §3.22 MPG, since TherapySelect is not a „health institution“.

  • Performing the CTR-Test® in Germany is not a „putting on to the open market“ as described in §3.11 MPG.

  • No particular official authorization or admission for performing the CTR-Test® in Germany, as well as no CE-brand, is necessary.

  • For the product-security, a conformity-evaluation-procedure must be done according to §9.1 of the guideline 98/79/EG of the European parliament from 27.10.1998 for In-vitro-Diagnostics.

  • TherapySelect can sell the IVD without consultation of certification bodies.

  • TherapySelect is subject to the supervision of the responsible national authorities.

  • The "Self-Certification" through TherapySelect is supplemented through the obligation to secure an appropriate quality-protection on the production-step. In this framework a technical documentation must be available, with which the suitability of the product and the declared accomplishment-data are proved comprehensible.

  • TherapySelect complies with all aforementioned requirements.

  • For the required quality-management TherapySelect has done this according to DIN EN ISO 13485 (for medical devices).


Just call us:

Monday to Thursday from 9:00 - 16:00
and Friday from 9:00 - 15:00

Our phone number:
+49 6221-8936-157

Send us a message:

We will get back to you as soon as possible.
Your TherapySelect Team


Our Awards

Award for innovative research
Award from the Federal Ministry of Education and Research, Germany
Award from the Federal Ministry for Economic Affairs and Energy of Germany
Award from the European Union