Profile
Manufacturing & Quality
All HUMAN instruments emphasize functionality and modern workflow requirements to meet customer and market demand. A fast-growing line of innovative products – meeting high European standards and bearing the CE mark – continues to be the essence of HUMAN’s success. HUMAN’s state-of-the-art production facilities in Magdeburg operate in accordance with the latest quality standards, guaranteeing consistent quality at the highest level. German values coupled with a global perspective have always been – and always will be – the cornerstone of our mission to provide “Diagnostics Worldwide”.
HUMAN manufactures diagnostic products of highest quality in full compliance with quality system standards (DIN EN ISO 13485:2009 and DIN EN ISO 9001:2008). HUMAN's quality management system has proven to be equivalent with GMP requirements as demonstrated by successfully passed inspections from other authorities. The most modern equipment operated by best-trained personnel guarantees the greatest reliability and flexibility.

HUMAN manufactures diagnostic products of highest quality in full compliance with quality system standards (DIN EN ISO 13485:2009 and DIN EN ISO 9001:2008). HUMAN's quality management system has proven to be equivalent with GMP requirements as demonstrated by successfully passed inspections from other authorities. The most modern equipment operated by best-trained personnel guarantees the greatest reliability and flexibility.

HUMAN's product philosophy calls for the utmost in reliability and quality as well as timely product availability. One of the keys to our success is the continuous optimization of our comprehensive Quality Management System.
Human is among the first companies in Europe whose products have been confirmed to comply with the requirements of the European In Vitro Diagnostic Directive (98/79 EC), probably the most demanding and strict regulation worldwide! HUMAN is regularly audited by its Notified Body (mdc) and has received EC-Certificates for Annex II (98/79 EC) products.
The CE mark on our products stands for the highest possible quality in compliance with the extremely stringent European IVD regulation.
We are proud that over the years our products have gained a reputation for quality worldwide.
Quality Certificates (in english)
- CE Certificate (Annex IV, Section 3)
- CE Certificate (Annex IV, Section3) Blood Glucose
- CE Certificate 1i-hiv
- CE Certificate el-hiv
- CE Certificate el-hbsag
- CE Certificate el-hivagab
- CE Certificate el-hcv
- CE Certificate ih-HumaType (Annex IV, Section 4)
- EN ISO 9001
- EN ISO 13485
- EN-ISO 13485 CMDCAS
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