Confirmed Quality Control System State Standard EN ISO 13485: 2018 (EN ISO 13485: 2016, IDT; ISO 13485: 2016, IDT), acting on the enterprise PE «VEL».
Quality management system compliance certificate
Certification of the Neysi-3M neurostimulation system
The certificate of conformity of the NeySi-3M neurostimulation system to the Technical Regulations for active implantable medical devices approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 № 755 was obtained.
This technical regulation is based on Directive 90/385/EEC relating to active implantable medical devices (Directive AIMDD).
Certificate of conformity