Chromsystems Milestones
Investing in the future
The company's structures are being adapted to accommodate future growth. Concurrently, the expansion of the company headquarters is underway to create additional capacity.
Successful IVDR certification
Chromsystems has successfully achieved IVDR certification (IVDR 2017/746). This certification demonstrates the company's commitment to the highest quality standards and confirms its ability to comprehensively fulfil the demanding requirements of the EU regulatory authorities.
New assay for drug analysis
Chromsystems launches a new drug screening assay with significantly higher selectivity and sensitivity compared to immunoassays. With a panel of 108 drugs and metabolites, the assay enables both target screening and quantitative confirmation in a single run.
Expansion of the regulatory affairs department
Chromsystems is expanding its regulatory affairs capabilities to meet regulatory requirements, particularly with regard to IVDR. This further strengthens Chromsystems' leadership in the introduction of IVDR compliant products.
Assay automation
Chromsystems launches MassSTAR to automate workflows with Chromsystems assays. With intuitive operation, logged user access and full traceability, MassSTAR is designed to meet the needs of the clinical laboratory.
Opening of new headquarters
The new headquarters in Gräfelfing, near Munich, are opened. From production to R&D and sales, everything is under one roof. The new building is also extremely energy- efficient and climate-friendly, using green electricity and district heating from sustainable sources.
Introduction Therapeutic Drug Monitoring
MassTox® TDM Series A, the innovative and modular LC-MS/MS system for therapeutic drug monitoring, is launched. Initially with a panel of 100 compounds that can be determined with a single column and identical sample preparation. The panel has since been expanded to over 200 compounds.
Entry into LC-MS/MS-based diagnostics
MassChrom® Amino Acids and Acylcarnitine is launched as the company's first LC-MS/MS assay. It is used in diagnostic laboratories worldwide as part of newborn screening for the early detection of serious metabolic disorders
Quality Management System Certification
Chromsystems' ISO 9001 and EN ISO 13485 certification underlines the company's commitment to quality and safety. Since then, TÜV SÜD has regularly audited and confirmed compliance with the relevant standards.
Company expansion
With continued growth and strong customer demand, the need for laboratory and production capacity increases. To accommodate this, the company moves to larger premises.
Company founded in Munich
The success story of Chromsystems begins with the founding of the company in Munich. The first product is an assay for the efficient determination of catecholamines in serum or plasma using HPLC. It can be used, among other things, to diagnose pheochromocytoma.
