Jón Bergsteinsson
Clinical investigations play an important role in your journey of bringing a medical device to market. While the relevant standards are often perceived as difficult and complex, having a good...
Megan Wallin-Kerth
We all make mistakes. Despite a vigorous editing process, there may even be one in this article! Although everyone makes mistakes, not everyone owns up to them, and thus they miss an opportunity to...
Shaneé Dawkins
A scene from the movie Ocean’s 8 provides a surprisingly useful lesson on cybersecurity. The character played by Rihanna needs to hack into a security person’s computer. She looks up his...
Gleb Tsipursky
In an era when flexibility and autonomy are requirements, financial services leaders are ready to break the chains of traditional office norms. The results of a recent Deloitte and Workplace...
Scott A. Hindle
We are one year away from the 100th anniversary of the creation of the control chart: Walter Shewhart created the control chart in 1924 as an aid to Western Electric’s manufacturing operations. Since...
Rob Moorey
Growing medical equipment inventories and increasing technical complexity are demanding more than ever from the clinical engineering teams responsible for maintaining clinical assets. Simultaneously...
Stephanie Ojeda
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management...
Aymen Saidane
As the manufacturing world pushes toward the goal of zero-defect production, part inspection is critical. Sheet metal’s thinness, coupled with its susceptibility to warping, demands precision...
Steve Thompson
If you’ve ever enjoyed the experience of an audit or inspection, then you know it’s about as much fun as having your wisdom teeth extracted. As painful as audits and inspections may be, they are...
Bryan Christiansen
Deciding whether to repair or replace an asset can be difficult. That’s why maintenance and reliability managers perform an analysis to determine whether it’s more economical to repair a failing...
Douglas C. Fair
Today’s manufacturing systems have become more automated, data-driven, and sophisticated than ever before. Visit any modern shop floor and you’ll find a plethora of IT systems, HMIs, PLC data streams...
Melissa Stewart
Companies are always looking for ways to bring in fresh ideas and new perspectives. And in an ever-evolving digital world, you can’t blame them. Young talents possess the latest technological skills...
Stephanie Hinton
If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the...
Stephanie Ojeda
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in...
William A. Levinson
The difference between common (or random) cause and special (or assignable) cause variation is the foundation of statistical process control (SPC). An SPC chart prevents tampering or overadjustment...
Peter Nathanial
Last month, the heads of seven major American AI companies emerged from the White House with an agreement on “self-regulation.” On the other side of the Atlantic, Europeans debate the long-...
William A. Levinson
Inflation is a serious national issue. Credit agency Fitch Ratings just downgraded the U.S. credit rating—as in the “full faith and credit of the United States”—from AAA to AA+.1 This doubtlessly...
Stephanie Ojeda
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Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on...
Mark Graban
I can’t count how many times during the past 20 years I’ve heard executives complain that their people aren’t enthusiastically participating in their lean program. Leaders lament that while the...
Andrey Koptelov
In this age of rapid technological innovation, the introduction of sophisticated technologies in various industries has raised complex ethical dilemmas. As businesses strive to achieve financial...
