As a medical device regulatory and quality management (QMS) consultancy we place considerable value in holding our own ISO13485:2016 certified QMS.
We are therefore pleased to announce receipt of our new ISO13485:2016 certificate covering the following scope ‘European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers’.
Having this much sought-after certification underpins our ability to help, assist and guide manufacturers through this process, therefore if you are also looking to transition to the 2016 version of this standard or are ready to implement your own quality management system please do get in touch with us, we have a team of experts ready to help.
Email: info@advena.mt
