In July 2022, Chromsystems successfully obtained its IVDR certification (IVDR 2017/746 “EU quality management system certification”). This certificate clears the way for the company to bring products under IVDR regulation into the European market.
|EU IVDR Certificate|
ISO 9001, EN ISO 13485 and MDSAP
Chromsystems implemented for its manufacturing and quality processes a quality management system to meet the highest standards of quality and performance. In 2004, Chromsystems Instruments & Chemicals GmbH was certified for the first time in accordance with ISO 9001 and EN ISO 13485. In 2018, the company also obtained its MDSAP - ISO 13485 certificate for Australia, Brazil, Canada and the US. Since 2007 TÜV SÜD have regularly checked the company’s compliance with its standards and confirmed its conformity with a certification. Before the company’s kits are introduced to the market, they are comprehensively validated and verified, and the quality of existing products is continuously monitored.
|ISO 9001 Certificate|
|EN ISO 13485 Certificate|
|MDSAP - ISO 13485 Certificate (Australia TGA, Brazil ANVISA, Health Canada and USA FDA)|
Products for the detection of phenylketonuria, which comprise all reagents, controls and accessories for the tandem mass spectrometry analysis of amino acids and acylcarnitines, are tested separately and certified according to IVD-directive 98/79 EG by the notified body TÜV SÜD Product Service GmbH.
|EC Certificate Phenylketonuria|