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  • Fp55 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 6 years, 11 months ago

    Often times the case of insufficient design controls is actually the failure to establish good document management. The success of a medical device depends largely on its foundation. Good document management will consequently lead to clear and concise design controls. Clear organization of documents will allow the team to adequately update documents. Inadequately prepared Design Controls can lead to confusion among team members and even mistakes in several documents. For example, parameters that appear in more than one document might not be consistent due to insufficient management.