Certificates
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IVDR
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 into the European market in accordance with the IVD regulation.
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 a notified body has regularly checked the company’s compliance with its standards and confirmed its conformity with its certificates.
MDSAP - ISO 13485 Certificate (Australia TGA, Brazil ANVISA, Health Canada and USA FDA)
PKU
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 |
IFCC Certificates for CDT
