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Our Services
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EU Representative Services

"Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a Member State, he shall designate an authorized representative." CDG assists you in finding authorized representatives in EU. We have partnered organizations which provide EU authorized representative services.

We are authorized partner of MedNet GmbH.


Act as your primary point of contact for all European regulatory agencies.
Review your Technical File(s) or Design Dossier(s) for completeness.
Review proposed labelling for your device(s) to ensure they meet EU requirements.
Allow you to place the Europe contact information on your device labelling (Instructions for Use, labels, packaging, etc.)
Assist with general questions about your product in the EU.
Be available to interact between you and the European Competent Authorities.
Assist with (near) incident reporting to Competent Authorities, in cooperation with you and your distributors.
Protect the confidentiality of your documentation - as your EU.
Authorized Representative, we can only show your documentation to the Competent Authorities.


 
 
Inviting International Partners | looking for Independent competent auditor for QMS, EMS, OHSAS, FSMS & ESMS, CE-Marking, Medical Device..
 
 
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