Quality Standards

Certified partner for any assay development

Whether you need highly specialized knowledge or manpower to bring your concept to market, we are your trusted independent partner for any type of assay development using any type of technology on any type of analyser. We are ISO 13485 certified and boast our own FDA registered manufacturing facility, offering small to medium scale pilot and commercial production capabilities. Immunoassays, point-of- care (POC) tests or validation services – you can expect superior performance.

 

Proven development approach: quality, conformity and transparency

To ensure highest quality, conformity and transparency, we apply our proven New Product Development Process to all assay development. Naturally, EN 13612:2002 and EN ISO 23640:2015 requirements and applicable CLSI guidelines are incorporated in this process, as is writing part of the technical file you need for IVD registration.