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