Become part of our story
We want to shed light into darkness of directives and regulations, remove barriers to make quality management systems moving and lay the foundation of new systems. Get a part of our exciting story to see how we make our vision become true.
Swiss Medical Device Manufacturers must appoint an EU Authorised Representative
EU and Switzerland did not update mutual recognition agreement (MRA) considering the latest medical device regulations. Therefore, Switzerland became a “3rd country” and Swiss based Manufacturers must appoint an Authorised Representative within the EU / EEA from May 26, 2020[for both MDR cleared and MDD legacy medical devices.
Contact us for our simple and time saving EU AR services
Quality Management System on Google Drive!
In the aspects of collaboration there are few tools as intuitive and simple to use as Google Drive. All documents are accessible and editable by permitted users live and in real time in one centralised location.
Therefore we have developed a whole ISO 13485 and MDR compliant Quality Management System on Google Drive.
We guide you from the implementation of the System until the CE certification!