Premium Quality
100% „Made in Germany“
From development and manufacturing to shipping: at HumanOptics, all business processes take place in Germany—at our two locations in Erlangen and Sankt Augustin. This enables us to guarantee the highest quality and maximum product safety. Ensuring the quality of our implants is one of our core tasks.
This quality is appreciated by our customers worldwide, which is why our premium implants are already available in over 40 countries.
Made in Germany
Quality and safety through certified processes
All production steps are clearly defined and are checked at regular intervals by external and internal audits. Because all manufacturing steps are carried out exclusively in Germany, we retain complete control over every single phase of the process.
During our optimized and validated manufacturing process,Intraokularlinsen (IOLs) undergo multiple 100% inspections. This means that the product quality of each individual IOL is repeatedly checked and approved by our employees. This is how we guarantee the quality and safety of our implants.
TÜV-certified quality management
We are certified according to EN ISO 13485. Our quality management is regularly audited both internally and externally. Our quality management system is certified by TÜV Rheinland LGA Products GmbH.
EN ISO 13485 – Certificate_english
EU Quality Management System Certificate (MDR)
EU Technical Documentation Assessment Certificate (MDR)
HumanOptics recently received approval for the implant CUSTOMFLEX® ARTIFICIALIRIS by the US Food and Drug Administration (FDA). This means that patients in the US will also have access to optimal care for iris defects..
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HumanOptics represented at the 43rd ESCRS Congress in Copenhagen
News
We are pleased to announce that HumanOptics will be participating in the 43rd Congress of the European Society of Cataract and Refractive Surgeons (ESCRS) in Copenhagen, Denmark, from 12 to 16 September 2025. The ESCRS Congress is one of the most important international platforms for ophthalmologists, researchers and companies in the field of cataract and […]