Quality Talks with Gabriella Adlovits, The RAQS Manager

28/08/2020

The following interview is part of the Omixon interview series that we are conducting with Key Opinion Leaders at Omixon. The next interviewee is the leader of Omixon’s RAQSM team, Gabriella Adlovits, Head of Regulatory Affairs and Quality Systems Management, who talks about her experiences and the role of...

Omixon Migrates CE 694131 Certificate from BSI UK to BSI NL

26/02/2019

We are pleased to inform our customers that Omixon has successfully upgraded its ISO Certificate according to ISO 13485:2016 standard and migrated its EC Certificate from the BSI UK Notified Body (ID: 0086) to the BSI NL Notified Body (ID: 2797). Our updated EC Certificate – Full Quality Assurance...

Omixon is Now ISO Certified for Canada

26/03/2018

Omixon announce its Quality Management System complies with the requirements of ISO 13485:2003 certified by a CMDCAS recognised registrar. As a result Omixon’s QMS meets the Canadian Medical Devices Regulations for design, development, manufacture and distribution, servicing and customer support of In Vitro diagnostic reagents, kits and software...