Monday, November 25, 2013
BTI Biotechnology Institute renews and extends its CE Certification with TÜV-SÜD Product Service GmbH for the use of the PRGF – ENDORET® Kit in accordance with the technique of obtaining of plasma rich in growth factors (PRGF – ENDORET®)
BTI Biotechnology Institute renews and extends its CE Certification with TÜV-SÜD Product Service GmbH for the use of the PRGF – ENDORET® Kit in accordance with the technique of obtaining of plasma rich in growth factors (PRGF®)
BTI Biotechnology Institute has renewed its European Certificate of Conformity (CE Certificate) for its range of medical devices for obtaining and applying plasma rich in growth factors, PRGF – ENDORET®. The certificate was awarded by the German Notified Body TÜV SÜD Product Service GmbH, one of the main suppliers of certifications at the international level, and here declares that Endoret technology (PRGF) complies with all the requirements established for medical devices in accordance with the European Union Directive.
Thus, the German entity declares that BTI has implemented a Quality System that ensures the design, development and manufacture of the following medical devices in the PRGF – ENDORET® range: the PRGF – ENDORET® Plasmaterm Furnace, the PRGF – ENDORET® centrifuge and the BTI single-use kit. In addition, it certifies that these materials must be used specifically for Endoret technology, demonstrated in the scientific literature and patented as PRGF technology.
TÜV SÜD confirms in its certification that these devices are indicated for obtaining plasma rich in growth factors in various therapeutic applications, recognising the safety and efficacy of PRGF – ENDORET® technology specifically in:
Note that this renewal, valid until March 2015, in addition to confirming the safety and efficacy of PRGF – ENDORET® technology for the therapeutic applications in which it had previously been certified, new applications have been added, such as the symptomatic treatment of pain and joint function in osteoarthritis, verified by various clinical trials published in internationally recognised scientific journals.
The search for excellence in all processes and the commitment to offering health professionals products that guarantee maximum biosafety and efficacy are, for BTI, an essential pillar of its philosophy business.
