Demonstrating identification and traceability in all quality system processes is a must for medical device companies to comply with FDA regulations. To satisfy this compliance need, companies will need to connect related processes within their quality system to close the loop between related pre-…

Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety. If there’s any “spoiler alert” to this article, it’…

This story was originally published by Knowable Magazine. Working from home—formally known as telework—is here to stay. A 2021 survey of approximately 30,000 Americans concluded that, after the pandemic, 20 percent of all work days may continue to take place at home, vs. just 5 percent before.…

This story was originally published by MIT News. Two MIT professors have proposed a new approach to estimating the risks of exposure to Covid-19 under different indoor settings. The guideline they developed suggests a limit for exposure time, based on the number of people, the size of the space,…

The medical device technical file is a must-have document for devices to be sold in the European Union (EU) marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations. It’s essentially an “everything you must…

Food manufacturers must carry out numerous specific processes to check that the foods they produce and distribute are safe for consumers. Analytical testing plays a vital role in meeting that goal. Here’s a look at how such examinations raise food quality and purchaser trust. Checking foods for…

During the past year, the U.S. Food and Drug Administration’s (FDA) approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The Covid-19 pandemic required us to rework our business operations so that we could carry out our public health…

Iam often asked by customer service leaders how to get the CEO to care about customers. They are convinced there is a missed tactic that, if implemented, would have the C-suite camping out in the contact center and inviting customers to board meetings. When I outline a number of possible approaches…

Seems everybody has a horror story about health insurance: Kafkaesque debates with robotic agents about what is and isn’t covered. Huge bills from a doctor you didn’t know was “out of network.” Reimbursements that take months to process. It’s no secret that healthcare in the United States is…

Unfortunately, a website is no longer enough for a significant or successful digital presence. Essentially, a presence is nonexistent without some consideration of search engine optimization (SEO). But this, too, has become one of the basics of “going digital”—a must, rather than a “nice to have…

Here’s an unfortunate truth: The story of the Covid-19 pandemic is one of epic quality failures in almost every area imaginable. Although there have been some admirable successes, such as the food and beverage organizations that have ensured the continued safe delivery of food supplies to most…

Ending the pandemic depends on achieving herd immunity, estimated at 70 percent or even 80 percent to 90 percent of a population. With some 30 percent of Americans telling pollsters they have no interest in getting vaccinated, that’s cutting it a bit close. The numbers are even worse in many other…

Artificial intelligence holds great promise for improving human health by helping doctors make accurate diagnoses and treatment decisions. It can also lead to discrimination that can harm minorities, women, and economically disadvantaged people. The question is, when healthcare algorithms…

Recent surveys point to increasing frustration and, frankly, exhaustion among nurses across the country. Although attending to patients during the pandemic has exacerbated the challenges of the profession, nursing shortages have been reported on for well over a decade. It is incumbent on hospitals…

The terms “customer-centric” and “customer-centricity” get thrown around a lot; oftentimes, it’s quite clear that they’re being used out of turn. I believe “customer-centric” is often confused with “customer focus,” but the two are very different. Let’s look at some definitions. Customer focus …

More than 50 million Americans have received at least one dose of either the Pfizer or Moderna Covid-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as the Johnson & Johnson vaccine rolls out. The vaccine has been hailed as a game changer. It requires…

In the era of social distancing, using robots for some healthcare interactions is a promising way to reduce in-person contact between healthcare workers and sick patients. However, a key question that needs to be answered is how patients will react to a robot entering the exam room. Researchers…

In an article published by Quality Digest, Julias DeSilva addresses recent declines in ISO certification and poses the question, “Does quality matter anymore?” His conclusion is that even if you don’t get certified, you will still gain from a well-implemented management system. But what do…

It’s been about a year since the Covid-19 pandemic turned our world upside down, and that includes the world in which we work. Certainty has hung up its hat, normality looks unlikely to return, and unpredictability is here to stay for the long term. How can organizations manage in this context, and…

During the past year, we have seen more businesses make the digital switch and take services online than ever before. For many, an ecommerce offering was a means for survival during an incredibly volatile and unpredictable time. For others, an online focus has been slowly developing for some time…

It’s a commonly held belief, one that gets played out daily in organizations around the world: Employees who receive performance feedback are much more likely to improve their performance than those who don’t get feedback. But research tells us that it’s simply not true. Typically, performance…

Respect is an abused word. Weak minds use it as a placeholder for fear. Weak egos will demand it up front. Weak hearts will use it to attach themselves to people of bluster, wishing they could be so outspoken. We could do with a few more conversations about respect. We can see here, sadly, that…

From the earliest days of radioactivity research, radiation and cancer therapy have gone together like peas and carrots. But Zach Levine covered peas and carrots in an earlier blog post, so I will focus on radiation and cancer therapy. Shortly after Wilhelm Röntgen discovered the high-energy…

Undeniably, the power of data is unmatched. With an abundance of data collection opportunities available online, and with an increasing number of businesses taking them, the potential and value of such information is richer than ever before. And businesses are benefiting. Particularly where data…

I was fortunate enough yesterday to get my second Covid-19 vaccine. It was a giant relief, one that more than compensated for 24 hours of arm soreness. It was the peace of mind that, despite vaccine shortage or administrative challenges, I am now protected—at least 95 percent. The feeling of…