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What portions of 13485 and the quality system in general must be followed by a company that is utilizing a contract manufacturer for manufacturing and distribution and has a contract engineering firm that has conducted all design and development for the products. Is Section 7 applicable if the engineering and contract manufacturing contractors are doing the work?
Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.
Thanks,
Here I Am
Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.
Thanks,
Here I Am