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es364 replied to the topic "What are challenges will we face if we missclassify a medical device ?" – 1 year, 2 months ago
Misclassifying a medical device can result in a number of issues and difficulties that could compromise regulatory compliance. Misclassifying a medical device might end up in submitting the wrong type of pre-market submission (e.g., 510(k) instead of PMA, or vice… Read more»
