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17.04.2024

New ISO 13485 Certificates for Medipan & GA

New ISO 13485 Certificates for Medipan & GA Generic Assays

We are delighted to announce an important milestone for our organizations: Medipan GmbH and GA Generic Assays GmbH have both successfully obtained new TÜV certificates for their quality management systems. These certificates were issued by TÜV Rheinland LGA Products GmbH in accordance with the international standard EN ISO 13485:2016.

Commitment to Quality and Compliance – ISO 13485

The ISO 13485 certification shows compliance with global standards for quality management in medical device design, production, and distribution. For Medipan and GA Generic Assays, it reaffirms our commitment to high-quality, safe, and reliable operations. Additionally, the certification covers all aspects of our processes, from research and development to customer support. It also ensures that our procedures meet strict international regulatory requirements. As a result, laboratories and healthcare professionals can trust our products for consistent performance and accurate results.

Certified Excellence in Diagnostic Manufacturing

The certification confirms that both companies have implemented comprehensive quality management systems for the development, manufacturing, and distribution of in vitro diagnostic devices using immunological reaction systems. These include reagents, test kits, and analytical systems with integrated software for the detection and evaluation of infectious diseases, autoimmune disorders, inflammatory parameters, and endocrine conditions.

Strengthening Diagnostic Innovation

For Medipan, this recognition represents another step forward in its ongoing mission to deliver high-quality diagnostic solutions that empower healthcare professionals worldwide to make precise and reliable clinical decisions. Likewise, it underscores GA Generic Assays’ continuous efforts to provide innovative and customized products in the field of immunology and medical diagnostics.

Access to Certificates and Further Information

We are proud to receive this formal recognition of our quality and remain dedicated to advancing diagnostic excellence. Our teams will continue to uphold these high standards while driving innovation in laboratory medicine.

The new certificates for both Medipan GmbH and GA Generic Assays GmbH can be accessed via the following links:

For further information, please do not hesitate to contact us.