Services

We offer

Conformity assessment services as notified body for EU Regulation (EU) 2017/746

ISO 13485 certification to IVD manufacturers globally

Please use this link ISO 13485 Certification for more details.

IVDR notified body services available from Sertio

IVDR Annex IX conformity assessment service for

• Class D

• Class C

• Class B

• Class A sterile devices

Annex XI conformity assessment service for

• Class A sterile devices

Classify your devices and determine the correct conformity assessment route. In case you need a notified body, we can deliver. 

Send your details and receive a quote

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All conformity assessment services are subject to availability.