TÜV Rheinland Italia delivered certificate CE in accordance with the new Regulation 2017/745 (MDR) to QURA

On September 6th, 2023, TÜV Rheinland Italy, represented by Massimiliano Testi, Local Field Manager of the Medical Devices Department, and Claudia Vimercati, Product Assessor and Project Manager, delivered to Raffaella Tommasini, QA&RA Director of Qura, the CE1936 Certificate in accordance with the new Regulation 2017/745 for the Hybrid Reservoir sterile disposable device.

Qura is an Italian company based in Mirandola, in the province of Modena, part of the Spectrum Medical LTD group. It is dedicated to the development of advanced technologies aimed at providing top-notch therapies and improving performance and outcomes on patients.

The Hybrid Reservoir is a state-of-the-art device designed for cardiac surgeries requiring extracorporeal support for up to six hours. Featuring an innovative combination of a venous reservoir-the result of the amalgamation of a rigid container and a soft bag-and a reservoir dedicated to cardiotomy blood management. This hybrid solution combines the convenience of a rigid system with the safety of a soft bag, minimizing the use of manual techniques for air removal.

As part of this certification process, TÜV Rheinland carried out a number of specific evaluations, taking advantage of targeted technical expertise, especially in relation to the conditions of use of the Hybrid Reservoir, focusing particularly on the behaviour of the blood fluid. Great emphasis was placed on the in-depth study of production technologies and skills employed by Qura. Operational audits at the company confirmed the scrupulous attention in manufacturing and the fulfilment of all requirements necessary to ensure a safe product that can confirm expected performance.

This achievement is of fundamental importance, both for Qura, which made a strategic choice in certifying its product according to the new EU Regulation 2017/745, guaranteeing high standards, and for TÜV Rheinland Italia. The latter, thanks to its rigorous approach and experience in the field, reaffirms itself as a certainty of safety in the world of medical devices.