MDR designation

CE Certiso Kft has been designated as the 12th notified body for conducting conformity assessment under MDR (Regulation (EU) 2017/745 on medical devices).

For further information you can visit the following site: NANDO

Saturday, 21 March 2020 23:53

INFORMATION!

Dear Partners!

Dear Inquirers!

Given the current situation, our company  is also working to carefully manage the risks posed by Coronavirus (COVID-19)…

Monday, 16 March 2020 12:01

Transition planning for ISO 13485:2016

We kindly inform our clients that accreditation procedure of our company CE Certiso Ltd for ISO 13485:2016 is in process. From January 2018…

 

Monday, 25 September 2017 10:50

 

The new regulations were published

The medical device / in vitro device device sector faces a challenge: as Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) have been published…

 

Monday, 25 September 2017 10:26

Transition planning for ISO 9001:2015

We kindly inform our clients that accreditation procedure of our company CE Certiso Ltd for ISO 9001:2015 is in process…

 

Tuesday, 13 December 2016 13:51

 

New revison of MEDDEV 2.7.1

The new revision (rev 04) of MEDDEV 2.7.1 Clinical evaluation: Guide for manufacturers and notified bodies has been published on the website of the European Commission…

 

Thursday, 14 July 2016 10:04

 

Successful re-designation till 2020

We have just received the decision of our Competent Authority (ENKK) on the re-designation of our notified body in the field medical device directives …

 

Tuesday, 15 September 2015 20:39

 

Occupational training at CE Certiso Ltd.

CE Certiso’s ’Occupational trainings for the development of CE Certiso Ltd’s competitiveness’ TÁMOP-2.1.3.A-12/2-2012-0355 project…

 

Friday, 01 February 2013 02:00