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• Compliance with harmonized (EU) standards
• Being a contact point with the various National Competent Authorities of the EU member states
• Managing National Competent Authority registrations, NCA discussions, vigilance reporting and more
• Facilitate communication with relevant competent authorities in the EU regarding safety and efficacy of medical devices
We primarily work with companies that don’t have a legal entity within the EU. QAdvis is an independent EAR and we separate the regulatory from the distributor’s aspects. We do not act as distributor of the medical devices nor are we part of the design and manufacturing.