Küsimused

Good Morning,

this is Mattia Russo from TSQ, a consultant company that offers several services. We’re offering an EU Representative service to an American manufacturer who want distribute a software as medical device (class IIa, only for professional users) in the Estonian market.

I would understand what the specific requirement is for:

-Language of Declaration of Conformity

-Fees to be paid for this kind of medical device

-The registration of the medical device inside the Estonian national data bank for medical device or Eudamed.

Thank you in advance.

Cordiali Saluti / Best Regards

Dott. Mattia Michele Russo, QARA Consultant Coordinator & Project Manager

ISO 13485 CERTIFIED 
MEDICAL DEVICE CONSULTING SERVICES

[email protected]

Via Leopardi,  Asti

Tel.  +39 0141 943426

[email protected]

www.tsquality.it

TS Q&E GmbH

Theilerstrasse 7
Zug (CH) 

[email protected]
www.tsquality.ch

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