Quality Assurance

Quality Assurance Policy
IDL Biotech shall supply products with high quality that are of great clinical use to the customer. IDL Biotech shall comply with regulatory requirements on markets where its products are intended to be used and is committed, with best effort, to customer requests. IDL shall maintain and continuously improve the effectiveness of the quality system.

Quality Management System
IDL’s Quality Management System is certified according to EN ISO 13485:2016. Annual audits of the Quality Management System are performed by DEKRA.

CE Mark

The CE mark (Conformité Européenne) on an in vitro diagnostic medical device (IVD) indicates that the device meets the European Union’s safety requirements. The CE mark is required to be able to sell the device on the European market as an IVD.

IDL Biotech’s CE marked products conforms to the requirements in ”In vitro diagnostic medical devices (98/79/EC).”