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 Cancer Therapy Response-Test (CTR-Test®)

 

QM-System

Specific information

Summary:

  • 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).