Tieto Finland Oy

Certificate CR-03-1226-911-26

Rev. 01Supplemented

Valid until: Aug 11, 2028

Certificate CR-03-1226-911-26 is a valid Quality management system issued to Tieto Finland Oy and registered in EUDAMED. Valid until August 11, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1226-911-26
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 7
Certificate ID: 0537CR-03-1226-911-2601

Validity

Issued: Apr 27, 2026
Valid from: Apr 27, 2026
Valid until: Aug 11, 2028

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented
Supplemented

Supersedes

CR-03-1226-911-26Quality management systemAmendedApr 27, 2026 → Aug 11, 2028

Scope coverage

Class IIb3Class IIa3

5 scopes

MDA 0315 Software
Class IIbClass IIa
Lifecare Lääkitys (v30.1.1)
Class IIb
Lifecare Patologia (QPati) (v1.1)
Class IIa
Lifecare Yksilöllinen Lääkehoito / Lifecare Personalized Medication (v1)
Class IIb
Lifecare Journal (Lifecare EHR v30.1.1, Lifecare Open Platform v1.0)
Class IIa