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Looking for ISO13485 Consultant CE Marking - Austin, TX

Z

zkoulou

#1
Hi,
I am a one man company, with a small budget, located in Austin TX. I am involved in ophthalmic medical devise. I do not manufacture anything. I will outsource all operations. I would like to market liquid medical devise in Europe. The medical devise is classified Class IIb. the liquid is injected into the human eye.
I am aware I need an ISO 13485 before I can request a CE.
This looks like a small project. Any consultant with expertise willing to help?
Thank you. Zak
 


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