Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers.

If there’s anything the last decade has taught us—and the Covid-19 pandemic has punctuated in grand fashion—it’s that businesses must get digital or they may become invisible.

The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485.

Medical laboratory professionals form the backbone of healthcare and the public health system.

Chickens come home to roost, and canaries meet their demise in coal mines. But hey, we knew there was a high probability of each happening eventually, right? However, when a black swan shows up with severe impact and consequences, everyone is caught off guard.

It all started when we drove up to the speaker menu at a quick-service restaurant. “Can I take your order?” the attendant coldly barked.

Paraphrasing Winston Churchill, Rahm Emanuel, a former White House chief of staff and Chicago mayor, famously quipped that you never want a serious crisis to go to waste.

Although the announcement, “FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce,” is a bit to fully digest in one sitting, I’m intrigued by the FDA’s focus on pre-harvest risk assessment of water risk as

The ISO 9001 standard talks about the relationship between the company and the customer in a couple of places. First is management’s responsibility to make sure that customers’ needs are a top consideration, and that their requirements are met.

As customer demands for more customization and choice increase, the complexity of products and associated product design, manufacturing, and sales processes also increase.