Have you implemented an ISO 13485 compliant training system, but are still struggling to determine how to evaluate the effectiveness of training actions? You’re not alone. The effectiveness aspect of ISO 13485 clause 6.2 is something that causes the most difficulties when implementing a medical device QMS. You know your employees are trained and management … Read more
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
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