Emosis is proud to announce that company’s certification under the norms ISO 13485:2016 and ISO 9001:2015 is maintained for the fourth year!
This achievement underscores that Emosis demonstrates the sustained focus and vision required to maintain and continually improve company’s ISO-based quality management system (QMS).
It is a critical step to successfully prepare forthcoming audit and (re-)certification of Emosis products by a Notified Body according to the new EU legislation applicable to in vitro diagnostic (IVD) medical devices, Diagnostic Regulation (IVDR) (EU) 2017/746.
This regulation that considerably strengthen the emphasis on certain essential aspects of the CE marking regulatory process, such as risk-based classification, conformity assessment and product certification including performance assessment by third-party independent Notified Bodies designed by the Competent Authorities of each EU member state, and post-market performance surveillance and reactovigilance.
We are thankful to our teams that are already committed to develop Emosis products consistently with the requirements of this new regulation which will ultimately improve the quality of care for the patients.