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®)
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).