Our Mission
Distribution of Medical Devices in France - Specialized in Urology and Gynecology
Efficient - Competent - Rigorous
The medical devices sector has special requirements, unique to this field of activity.
We are experienced in the distribution of medical devices and specifically surgical implants for more than 20 years, with perfect knowledge of the requirements to access to the person in charge.
Urology and Gynecology
Our network is more specially developed with specialists in urology and gynecology, with regular visits to hospitals and decision-makers.
Distribution center based in Lyon
Our location allows us to easily reach out to all regions to guarantee an optimized delivery time.
EU Authorized Representative
Pickup a reliable partner to handle the new regulatory challenges
EU Authorized Representative - MDR 2017/745
European regulations require the identification of an authorized representative for all manufacturers headquartered outside the European Union.
"Authorized representative" means any natural or legal person established in the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on behalf of the manufacturer for the purposes of carrying out specific tasks related to the obligations incumbent on the latter under the regulations (verification of presence of DoC and technical documentation).
An agent must also keep copies of all documents available to the authorities and allow them to access them upon request. These are the technical documentation, the declaration of conformity and the certificates, including their modifications and additional documents (Article 11 (3) (b) of the two regulations).
In addition, authorized representatives must verify that the manufacturer has recorded the required information in EUDAMED.
