Access Europe

– 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-European manufactures of medical devices to comply with European directives. We have a large international network within the industry and is a member of the European Association of Authorised Representatives (EAAR).

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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.

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Contact me for further information
Maria Eklycke
Office +46 8 621 01 05 or send me a mail