There are multiple aspects involved in the process of CE marking a medical device for commercialisation across the European Economical Area (EEA). An ISO 13485 Quality Management System (QMS) for medical products and processes can help manufacturers demonstrate that they have the required systems in place before proceeding with creating a technical file for a CE mark application.
MD-TEC can assist small and medium-sized enterprises with:
Accelerating the translation of R&D through ISO-accredited characterisation of devices from testing, design and manufacturing processes.
Advice and guidance on QMS implementation at your facilities.
Ensuring that you can meet the requirements of the MDR / IVDR for technical documentation.
