About us

Sertio

Sertio acts as a conformity assessment body and has specified to conformity assessment of IVD devices and QMS. Sertio primary focus is to act as an EU notified body under IVDR. Sertio was founded in 2021. Company is located in Finland.

Our goal is to ensure patient safety and provide IVD manufacturers and subcontractors an efficient approach to certification. As we focus exclusively on IVD medical devices we can fully utilize the considerable experience in the IVD medical device industry and prior notified body experience to customer benefit. We believe this builds the frame for a successful long-term co-operation with us.

As of today the growing team of Sertio has extensive amount of IVD work experience and IVD notified body experience in conformity assessment. Our team of experts include certifiers, internal clinicians, product reviewers, lead auditors and clinical specialists. All conformity assessment personnel go through vigorous training and qualification process prior to being authorized. Only authorized personnel can conduct conformity assessment. Also due to competence requirements we continuously strive to update our expertise and competence.

Impartiality policy

Sertio Oy is dedicated to act responsibly in the conformity assessment field. 

• We strive to fulfill the regulatory requirements

• We provide high quality conformity assessment service to our customers

• We act ethically in all of our actions

• Remuneration of personnel is not dependent on the outcome of the assessments

• Bonuses for obtaining new customers are not paid for Sertio Employees

• We ensure confidentiality, independence and impartiality within our operations

• We will not provide consultation services or pre-certification

• We will not provide customer specific trainings or internal audits

• We will not tolerate discrimination or inequality

Sertio Oy management declarations of interest.

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