FDA

FDA Warning Letter: Forcemech

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Welcome to the first installation of Warning Letter of the Week (WLOTW). Each week, we will review a different FDA Warning Letter, to gather as much information as possible to avoid repeating those mistakes. The Warning Letters will range from recently posted letters to letters covering specific markets, and anything else I find interesting. If … Read more

ISO 13485 Complaint Handling: The Definitive Guide

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A medical device company’s complaint handling system is one of the most essential elements of its quality management system. A bad process will leave the company with an increased likelihood of audit findings, and present the company with possible legal and regulatory consequences. A good ISO 13485 complaint handling process can lead to increased customer … Read more