Certification of quality management system for medical devices
Regulation UNE-EN-ISO 13485:2016
LGAI Technological Center, S.A. (Applus+) certifies that the Quality Management System for Medical Devices of the company:
CUSTOM IMPLANTS, SL, Polígono San Cibrao das Viñas, parcela R6-13, sector C1, 32911, San Cibrao das Viñas (Orense) for the development of “Design and manufacture of custom-made implantable prostheses, surgical guide fixation systems, orthoses and anatomical models, using CAD/CAM applications and additive technologies, 3D printing and machining'.
complies with the requirements of the regulation UNE-EN-ISO 1385:2016
DATE OF ISSUE: 06/11/2020
EXPIRY DATE: 05/11/2026