A laser die cutting machine uses light instead of hard tooling and hard steel blades. As a result, your materials are going to react differently,…
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The business world loves its innovators. Yet for all the hoopla about the Apples, Googles and start-ups in the world, the number of companies that…
September 24 has become a date that inspires anxiety among medical device manufacturers. September 24, 2014 was the UDI (unique device identifier) compliance deadline for…
The current regulations are the result of a final rule released in September of 2013 by the FDA, which stipulated that most medical devices carry…
Dr. Cohen, who sadly passed away in 2021, was considered one of the industry’s foremost experts in all aspects of the web coating experience. After…
There’s an old saying: Stuff happens. When it comes to a converting production line, “stuff” manifests in the form of defects, such as: Parts not…
Good Automated Manufacturing Practices (GAMP) are the guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Because of the regulatory nature of…
What do we mean by modularity? Wikipedia gives us the broad-based definition of modularity in relation to manufacturing: “In manufacturing, modularity refers to the use…
Henry Ford once said that if he made what people asked him for, he’d have invented a faster horse. That’s the thing with innovation:…
All devices as defined by 21 USC 321 (h), i.e., a “medical device,” are subject to the requirements of the UDI rule unless an exception…
