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Patrick Gale
Medical equipment is a necessary yet substantial investment for any health system. Making strategic decisions about these assets can be daunting in the face of shifting patient demand, financial uncertainty, and fast-changing cybersecurity risks.
Because clinical assets account for an average of…
Mike Figliuolo
If you have kids, you know the nauseating feeling of one of them going down for the count and having to rush them to the emergency room. I had that grim experience recently. What I learned from that ER visit is businesses can make very strong statements about how little they care about their…
Jones Loflin
When we talk about a lack of work-life balance, stress, or burnout, one of the things we’re actually saying to ourselves is that we feel we have no control over the outcome or our future. It can feel like the line between work and life has blurred into one big, overwhelming blob.
It’s time for a…
Alonso Diaz, Maria DiBari
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…
Maggie Overfelt
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…
NIST
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…
Stephanie Ojeda
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…
Jamie Bihary
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…
Stephanie Ojeda
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…
Michael King
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…
Meg Sinclair
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…
Kristi McDermott
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…
Alonso Diaz, Maria DiBari
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…
Scott A. Hindle, Douglas C. Fair
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…
ComplianceQuest
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…
Kari Miller
Traditionally, quality management in the pharmaceutical industry has strayed away from artificial intelligence (AI) for fear of setting it loose with such sensitive information. They have been cautious of implementing an additional element of intelligence into their process. But will organizations…
Del Williams
To provide food processors with insight into the industry’s current challenges and opportunities, Cablevey Conveyors, a global specialty conveyor manufacturer, and Automated Handling Solutions, a service-focused subsidiary of Cablevey, have released results from an annual proprietary survey…
Stephanie Ojeda
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.
In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective.
Today, document management has become the…
Brad Jobe
Artificial intelligence (AI) has the potential to reshape the healthcare industry. There is a massive amount of healthcare data available for AI to process. Nearly one-third of the world’s data volume is generated by the healthcare industry, and the volume of big data is projected to increase…
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 grasp of them makes the process less confusing.
Understanding ISO 14155:2020 is essential. It’s a guide to…
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, a shrinking talent pool of biomedical equipment technicians (BMETs) could lead to large staffing…
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 System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With…
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 necessary to bring needed medical products to market and monitor them to protect consumers and patients…
ISO
Healthcare administrators find themselves at the fore of a demanding and transformative field, where the pursuit of excellence in patient care is nonnegotiable. In a health industry landscape facing evolving regulations, escalating costs, and an increasing emphasis on patient outcomes, the need for…
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 CIR to that member state.
The European Union Medical Device Regulation (EU MDR) lists this as one of…