ISO certificates

Quality, safety and reliability are at the heart of everything we do.

AESKU® has a comprehensive quality management system that is certified in accordance with ISO 13485:2016 – the international standard for manufacturers of medical devices.

This certification confirms that all processes – from research and development to production, service and sales – meet the highest quality and safety requirements.
It ensures that our in-vitro diagnostics, reagents and software solutions for the diagnosis of autoimmune and infectious diseases are developed and manufactured under strictly controlled conditions.

In addition, Aesku.Diagnostics GmbH & Co. KG and AESKU.BION are certified in accordance with the Medical Device Single Audit Program MDSAP. MDSAP enables us to meet the regulatory requirements of several countries – including the USA, Canada, Brazil, Japan and Australia. This enables us to ensure uniform global quality standards and maximum product safety in all target markets.

Aesku.Diagnostics GmbH & Co. KG is also certified in accordance with the harmonized European standard EN ISO 13485:2016 in the context of the IVDR, which integrates the European requirements for medical devices. In this way, we comply with both international and European regulations and create transparency and trust – with authorities, partners and users alike.

These certifications are an expression of our commitment to combining innovation with responsibility. They show that we not only focus on scientific excellence, but also on consistent compliance with regulatory requirements – for reliable diagnostic solutions that specialist users worldwide can trust.