New ISO 13485 Certificates for Medipan & GA Generic Assays

We are pleased to announce that both Medipan GmbH and GA Generic Assays GmbH have obtained new TÜV certificates for their quality management systems. These certificates were issued according to the requirements of EN ISO 13485:2016 by the certification body TÜV Rheinland LGA Products GmbH.

The certificates confirm that both companies have implemented rigorous quality management systems for the development, manufacturing, and distribution of in vitro diagnostic devices with immunological reaction systems. These diagnostics include reagents, test kits, and analysis systems with integrated software for the detection and evaluation of infectious diseases, autoimmune diseases, inflammatory parameters, and endocrine disorders.

For Medipan, this represents further confirmation of their commitment to providing high-quality diagnostic solutions to support healthcare providers worldwide in making precise and reliable diagnoses. Similarly, it underscores GA Generic Assays’ efforts to offer innovative products and customized solutions in the fields of immunology and medical diagnostics.

We are proud to receive this recognition of our quality standards and remain committed to providing our customers with high-quality products and services.

The certificates for both Medipan GmbH and GA Generic Assays GmbH can be found with the following links:

• ISO 13485 Medipan
• ISO 13485 GA Generic Assays

For further information, please contact us.