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The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
The U.S. Food and Drug Administration (FDA) emphasizes the importance of being prepared for device recalls.
FDA product recalls are on the rise in the post-pandemic era. There has been a clear upward trend from 2021 through 2023, and medical devices ranked the highest of all product types. (See…
It’s important to have customer-friendly policies if you want to have a great customer service culture. Your policies drive team behaviors, so be sure they’re consistent with the brand you want to put forward.
I’m going to hark back to my recent post, “$325 Equals $210? The Math of Customer-…
Michele Gelfand finds inspiration for new projects all around her: taking in the banter in a boardroom, speaking with taxi drivers when traveling, observing the interactions between physicians and nurses during an unexpected trip to the doctor. The idea for one of her most recent papers was sparked…
Stain-resistant clothing, fast-food wrappers, and extreme weather gear such as certain jackets and pants—these products get many of their desirable features from a class of manufactured chemicals called per- and polyfluoroalkyl substances (PFAS). But there’s a major downside: Researchers have found…
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the opportunity to bring process issues into the open before…
An internal audit can be an overwhelming prospect, especially if you’re new to a company or internal auditing in general.
The MedTech space is huge, and even the standards that are meant to help, like ISO 13485:2016, cover a lot of ground.
So, if you’re part of the audit team in your company, and…
Many people proclaim they are gurus, ninjas, and other silly titles. Giving yourself such a title can cause people to lose respect for you, and it can cost you credibility.
Titles matter. A lot. So do email addresses and signature blocks. As unfortunate and as shallow as it is, people make a first…
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for example, designate a formal unit for managing…
As a manufacturer, you understand that supply chain disruptions happen all the time. What you don’t know is when or how they will affect your operation and business. But assessing your supply chain risks and implementing good supply chain management practices can be daunting. This is especially…
As a manufacturer, you understand that supply chain disruptions happen all the time. What you don’t know is when or how they will affect your operation and business. But assessing your supply chain risks and implementing good supply chain management practices can be daunting. This is especially…
In the ever-evolving life-sciences industry, market share is fiercely contested and companies must continuously optimize their operations to maintain their competitive edge.
Modern technologies and intelligence-driven solutions are revolutionizing how organizations work, empowering them to elevate…
At Qualio, our mission is to help life science companies embed robust digitized quality to get their critical products to market at rapid speed and keep them there. And because the Qualio+ team combines over a century of collective quality and regulatory experience from within the life science…
Is the customer really always right? We throw that comment around haphazardly without truly considering the ramifications of such an approach. I’d submit that they’re not. There are plenty of times the customer is wrong (and sometimes, very much so).
First, let’s explore the implications of a “…
Technology has reshaped the healthcare industry, empowering clinicians, technicians, and executives to better serve patients and achieve their goals. However, technology doesn’t eliminate the need for human oversight and management. Healthcare technology will continue to advance at a rapid pace in…
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine.
The rise has more than doubled within three years of post-pandemic…
If you have a new business idea, I’m excited for you. If you ever want to get it off the ground, however, be sure you have a problem. A real problem. I know that sounds cryptic. Allow me to explain.
When I hear a new pitch, the first question I ask is, “What’s the problem?”
You would be surprised…
Since generative AI went mainstream in 2023, it has inspired an equal measure of hype and fear. Boosters of tools such as ChatGPT and DALL-E predict that they will transform our economy, while skeptics worry about their potential to produce inaccurate or harmful results and ultimately replace…
So far in this series our focus has remained on statistical process control (SPC) in manufacturing. We’ve alternated between more traditional uses of SPC that remain relevant in this digital era and discussing uses of SPC and its related techniques that are enabled by the marvels of modern…
So far in this series our focus has remained on statistical process control (SPC) in manufacturing. We’ve alternated between more traditional uses of SPC that remain relevant in this digital era and discussing uses of SPC and its related techniques that are enabled by the marvels of modern…
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
Quality consistently ranks among organizations’ foremost competitive priorities; it’s a prerequisite for success in the global marketplace. Firms that want a competitive edge do it by delivering products that meet customer needs and function as intended.
Despite the long-standing emphasis on the…
By eliminating low-value work from your life, you can focus on more important things. Get rid of difficult customers and focus on driving your business instead.
To get your new year started right, I’d like to share with you what I’ve been taught by homemade bread, lawn mowers, and cheap customers…
Today’s quality leaders in the life sciences industry have nearly impossible charters. Long-term trends and sudden black swan events in combination can hinder an organization’s ability to exert control over product quality. Globalization, labor shortages and strikes, outsourcing, just-in-time…