Sertio a Kiwa company

Sertio – a Kiwa company: specialized conformity assessment for in vitro diagnostic medical devices

Sertio, now part of Kiwa, is a conformity assessment body based in Finland. Sertio specializes in in vitro diagnostic medical devices and quality management systems, serving customers globally. Sertio provides notified body conformity assessment services under Regulation (EU) 2017/746 on in vitro diagnostic medical devices, known as the IVDR. Sertio is also a FINAS-accredited certification body providing ISO 13485 quality management system certification.

On 1 May 2026, Sertio Oy joined Kiwa Oy. The acquisition strengthens Sertio’s position as a trusted expert in conformity assessment for in vitro diagnostics and gives customers access to Kiwa’s international network and expertise.

As part of Kiwa, Sertio can serve its customers more comprehensively while maintaining the expertise, service quality and customer focus that characterise Sertio.

Established in 2021

Sertio was founded in 2021 and is located in Finland.

Specialized in IVD devices

Sertio focuses on conformity assessment for in vitro diagnostic medical devices and related quality management systems.

IVDR notified body

Sertio provides notified body conformity assessment services under Regulation (EU) 2017/746.

FINAS-accredited certification body

Sertio provides ISO 13485 certification to IVD manufacturers, organisations operating in the IVD field and sterilisation service providers.

Serving customers globally

Sertio is based in Tampere, Finland, and provides its services to customers internationally.

Why choose Sertio?

Sertio’s goal is to support patient safety and provide IVD manufacturers and subcontractors with an efficient approach to certification.

By focusing on IVD medical devices, Sertio can apply its experience in the IVD medical device industry and notified body conformity assessment to the benefit of its customers.

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.

ISO 13485 is the medical device industry's quality management system (QMS) standard. The scheme specifies the requirements for a quality management system for medical devices.

Blurred hospital ICU with medical monitors in the foreground and two healthcare workers attending a patient in the background.

Medical Devices are an heterogeneous category of products, such as active equipment, orthopaedic implants, reusable instruments, substances and materials, software, and more. These devices, designed for medical purposes and intended for use in or on humans, achieve their primary effects through mechanisms other than pharmacological, immunological, or metabolic actions. Before entering the European Economic Area (EEA) market, the medical devices need to be compliant to applicable legislation and obtain the CE marking.

Kiwa Notified Bodies are able to provide all the necessary services to obtain comprehensive answers and reliable information on the Medical Device certification process in accordance with Directive 93/42/EEC. Thanks to the experience of Kiwa Notified Bodies, companies of the medical sector can demonstrate compliance with the essential requirements for medical devices and gain access to the European market, as well as obtaining prerequisites for access to other global markets. Moreover, thanks to the technical expertise of Kiwa Medical, medical device manufacturers can rely on a trusted partner, able to guarantee the execution of an effective conformity assessment process, which can combine the guarantee of market safeguarding with the business tool.