Certificates

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SurgicEye maintains the highest quality for all services, solutions, products, and processes. Download the relevant SurgicEye certificates. For further information and questions regarding quality management and regulatory affairs, please contact our quality management department at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

 

Quality Management System EN ISO 13485

alt EN ISO 13485 : 2003 + AC : 2007

 

Product Certificate for CSS300

alt Annex II - Selection 3 of Council Directive 93/42/EEC concerning medical devices

alt 510(k)

 
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