Is ISO 13485 a requirement for a non-manufacturing company? | Quality Digest

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› Is ISO 13485 a requirement for a non-manufacturing company?

Quality Digest | Tue, 10/11/2005

Hi all,

I hope someone can help me on this one. We are a start-up medical device company in the U.S. If we outsource the production of our product do we still have to be registered to ISO 13485 ?

And what is the situation in Europe? Do we need ISO 13485 certicate in order to be able sell in Europe?

I would appreciate your comments on this.

Biomed

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