3EC International a.s. is accredited for EN ISO 13485: 2016 standard.

Since 30.11.2017 3EC International a.s. is provides accredited certificates according to the new revision of EN ISO 13485:2016 standard.

Valid Certificate of accreditation is available here. The scope of the accreditation is stated in the Annex of the Certificate.

Archive

Socially Responsible Company 3EC International 20. 08. 2024
Conditions for extension of the transition period of EC certificates related to the “legacy devices” 28. 03. 2023
Award for an extraordinary contribution to the development of quality 14. 12. 2022
Application of IVDR requirements in place of the corresponding requirements of the Directive according to Art. 110 sec. 3 IVDR 06. 10. 2022
3EC International a.s. designated and notified according to the IVDR 03. 05. 2022
Socially Responsible Company 3EC International a.s. 05. 10. 2021
Application of MDR requirements in place of the corresponding requirements of the Directives according to Art. 120 sec. 3 MDR 01. 06. 2021
Information about 3EC International trade name misuse 11. 05. 2021
Socially Responsible Company 3EC International a.s. 25. 11. 2020
3EC International a.s. designated and notified according to the MDR 17. 09. 2020

1 2 3