Is a Consultant Required to Review a Quality Management System (QMS) or Submit a 510(k) Application?
Is it your first time submitting a 510(k) application for a class II medical device? Are you thinking you have a quality management system (QMS) in place and experience with drug submissions, so this should be easy?
Food and Drug Administration (FDA) device submissions are quite different than drug submissions and while having the QMS in place is important and necessary, it is not all you need to apply for device marketing.
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