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What are some ways to NOT maintain proper document control? Red-lined post-it notes, uncontrolled copies passed around during inspections, keeping master files on your desktop instead of in your eQMS system, and secret file cabinets in locked closets full of uncontrolled, red-lined specifications documents. And this is not a comprehensive list.
Keywords: medical devices, FDA 510 k process, medical device regulatory affairs, FDA 501 k, medical device regulation, FDA 510(k), regulatory affairs, FDA 510k approvals, regulatory affairs medical devices, regulatory compliance, risk management, quality management system, quality management, quality management in healthcare,
quality management system medical device, FDA submission, FDA 510k submission guidance