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.