Few things motivate FDA faster than a significant number of adverse events, especially deaths.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
The latest cybersecurity threat reveals how an insulin pump is vulnerable to hackers.
Charlie Chi, former CEO of OtisMed Corp, is sentenced to prison for shipping adulterated medical devices into interstate commerce.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
Some companies just don’t get it. If a device has been cleared or approved for a specific indication, it can only be advertised for that specific indication.
Take a quick trip to the FDA’s warning letter page and you’ll see the potential danger that novelty lenses pose.
The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.
The control of nonconforming product should never be an onerous task. Keep it simple by never allowing non-conforming product to make its way into your organization’s supply chain. While UAI is convenient, eventually the use of such concessions is going to break your heart.
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.