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We are a research centre, and responsible for product development for a private company. Our design work has come to the stage of product validation phase. Neither our research centre nor the private company has GMP ISO 13485 certification.
We are engaing a GLP lab to do all validation tests for us. But we need to prepare validation protocol before the test. I'm not sure whether the validation protocol issue by our research center are validate to be used in either CE or FDA certification.
We are really worry about this, could any experts here can help me?
Thanks a lot...
We are engaing a GLP lab to do all validation tests for us. But we need to prepare validation protocol before the test. I'm not sure whether the validation protocol issue by our research center are validate to be used in either CE or FDA certification.
We are really worry about this, could any experts here can help me?
Thanks a lot...