Quality & Certificates

Our minimum expectations are the highest possible quality

SurgicEye maintains the highest quality for all services, solutions, products, and processes. The high quality is the intrinsic philosophy of all actions performed by SurgicEye, its team, and selected partners.
The most relevant certificates are available for download the relevant SurgicEye certificates. For further certificates, information and questions regarding SurgicEye’s quality philosophy, quality management and regulatory affairs, please contact our quality management department at qmb@surgiceye.com.

EN ISO 13485

Quality Management System EN ISO 13485 : 2016 + AC:2016


CE Certificates

CE Certificate – Annex II – Section 3 of Council Directive 93/42/EEC concerning medical devices for declipse®SPECT Open Surgery,  declipse®SPECT Imaging Probe and DosePlan 1.0

FDA Approval

declipse®SPECT Laparoscopy

FDA Approval

declipse®SPECT Viewer