IVDR Notified Body Certification
Sertio, a Kiwa company, provides independent IVDR Notified Body certification services for in vitro diagnostic medical devices, supporting global manufacturers in CE marking and achieving EU market access.

Thanks to Kiwa's expertise, medical device companies can demonstrate that they meet the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. In addition, thanks to Kiwa Italia's technical expertise, medical device manufacturers can rely on a trusted partner that can guarantee the execution of an effective conformity assessment process, which can combine a guarantee of market protection with a business tool.