Quality Control

Quality Control

LDN has developed an extensive internal quality assurance program and our facilities are certified according to DIN ISO 13485:2003 + AC:2009 and 9001:2008. These norms are applied to all our operative and incorporated processes starting from the project design to the final product, from its market launch to its post-marketing surveillance.

All our in-vitro diagnostics fulfil the regulations of the European IVD directive (98/79/CE) and are CE-marked. Additionally, most of these products are listed with the FDA.

In addition LDN regularly participates in national and international external quality assessment schemes (EQAS). The different schemes comprise the determination of clinical samples (urine, plasma/serum) and samples related to food safety (histamine in fish):

Food Safety

CHEK (www.vwa.nl)

  • Analyte we report: Histamine in different kinds of fish-derived matrices

FAPAS (www.fapas.com)

  • Analyte we report: Histamine in different kinds of fish-derived matrices

Clinical

INSTAND (www.instandev.de)

  • Analytes we report: Catecholamines in plasma and urine, Serotonin in plasma and urine, 5-HIAA in urine, Metanephrine in urine, Normetanephrine in urine

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