Innokas

Lybe Scientific - How to build and deploy an efficient QMS with speed

Project timeline:

months

Service areas:

Quality and Regulatory

Written by

Innokas employee on a laptop with accompanied by "Innokas sustainability report 2024" title

Last summer, Lybe Scientific got its first product registered as a CE-marked IVD medical device fulfilling the requirements set by In Vitro Diagnostic Directive (IVDD). The company built an ISO 13485 compliant QMS in a short time with the help of Innokas’ QARA team and got registered as a legal manufacturer of in vitro diagnostic medical devices. This was a key milestone for further sales and marketing of Lybe Scientific’s products for diagnostic purposes.

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