Post Market Clinical Follow-up
The most important process in NeoCor's Products Quality Management System is its marketed products' effectiveness and safety surveillance.
In this view the company prepares and conducts post-market clinical follow-up, meeting the requirements given in the Eurasian Economic Commission Council Resolution "On the requirements for implementation, maintenance and evaluation of medical devices quality management system with regard to potential risk of their application" dated November 10, 2017.
The EEC requirements include manufacturer's obligations for post-market surveillance of the 3 risk class devices' effectiveness and safety, which includes all NeoCor's products.
In accordance with paragraph 8.3 of GOST R ISO 14155-2014 "Clinical investigations. Good clinical practice." The sponsor/organizer of a Clinical study might outsource some or all of the obligations or functions, including surveillance, to a third-party company.
NeoCor has selected OOO ST Medical (Ltd), a contract research organization, to conduct post market clinical follow-up www.ctmedical.ru
Here is the list of NeoCor's current clinical studies, which any interested health centres may join as one of the sites:
Post-market confirmation of safety and efficiency of UniLine PRESERVED XENOPERICARDIUM BIOLOGICAL HEART VALVE PROSTHESIS, MOUNTED ON A FLEXIBLE STENT used for mitral, aortic and tricuspid valves failure treatment (UNILINE)