We are pleased to announce that Advena Services Limited has successfully obtained their ISO 13485:2016 certificate from the Italian Notified Body IMQ, under the scope of MDR/IVDR Article 13 Regulatory Importer Service.
Additionally, Advena Limited were also re-certified under ISO 13485:2016 by IMQ, under the scope of European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers.
Both certifications were obtained with no non-conformities, owing to the great quality of work and high standards that the team at Advena constantly strives to achieve.
The certificate can be accessed using the following link; QMS Certificate
Any clients interested in understanding more about the importer servicer should email us at importer@advena.mt
