The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing.

I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls.

There’s a well-known aphorism that generals are always fighting the last war. It’s a natural human tendency to focus on the kinds of threats you’re used to while playing down the likelihood or importance of some new sort of attack.

CNC (for computer numerical control) machines have made manufacturing easier, faster, and more precise.

The Covid-19 pandemic brought to light a stark reality about current supply chains. As Nissan Motor’s chief operating officer Ashwani Gupta points out, “The just-in-time model is designed for supply-chain efficiencies and economies of scale.

‘Anyone can hit a home run if they try,” said the great Ty Cobb at the end of the deadball era as Babe Ruth rose to fame in the 1920s. Cobb was unimpressed by Ruth, the Sultan of Swat. “It’s a brute way to approach the game.”

Inflation has skyrocketed during the first half of 2022, which also saw a sharp downturn in the stock market in response to the Federal Reserve’s increase in interest rates to reduce demand.

The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.

Work has become an around-the-clock activity, courtesy of the pandemic and technology that makes us reachable anytime, anywhere. Throw in expectations to deliver fast and create faster, and it becomes hard to take a step back.

Florida’s outbreak of listeria has so far led to at least one death, 22 hospitalizations, and