Being a medical device company, it is essential to have a Quality Management System (QMS). With the support of external consultants, Oncodia has planned and prepared its QMS according to ISO 13485:2016 over the past year. ”-We launched timely in August 2019 and the software development has now transitioned into the QMS. We are now focusing on the technical files of our product to be able to affix the CE mark in Q2 2020” says Tom Adlerteg, Regulatory Implementation Manager at Oncodia.
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