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  • jnm22 replied to the topic Design Controls for Legacy Combination Products in the forum Introduction to Design Controls 9 years, 2 months ago

    I also didn’t think it would be difficult. There had to be some type of lab notebook or documentation process for the development part and for testing just pull the materials from manufacturing and go from there. I think the problem would be if it fails safety testing how can the company come back and fix it.