Access the European Union (EU) – Partner with QAdvis for your EAR representation
QAdvis is an expert in medtech quality system management, regulatory, compliance and more. One of our key competences is also to assist non-EU manufactures of medical devices to comply with European directives/regulations. We have a large international network within the industry and is a member of the European Association of Authorised Representatives (EAAR).
The Process – From Contact to Maintenance
Risk Management | Software and Cybersecurity | Marketing approval for medical devices, MD and IVD
Clinical evaluation and Performance evaluation | Biocompatibility assessment | Quality Management System for medical device manufacturers
PMS – Post Market Surveillance | Due Diligence | Usability | Acccess the European Union (EU) | Acccess the UK
