MedQAIR offers comprehensive medical device regulatory consulting services and solutions tailored for all medical device and IVD companies that do not have a physical presence within the EU. We operate as a European authorised representative (with a registered address within the EU) acting as your intermediary with national competent authorities. Our medical device regulation experts ensure that medical devices and IVDs comply with EU regulations, facilitating market access and ensuring patient safety.
In-country representation from a reliable European Authorised Representative, facilitating effective liaison with regulatory authorities.
Expert PRRC medical device services for compliance, guidance, and support for your regulatory needs.
Comprehensive MDR & IVDR Regulatory Services that assure compliance and market success with expert guidance.
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