All Features
Etienne Nichols
As part of its effort to address the changing landscape around artificial intelligence (AI) in medical devices, the U.S. Food and Drug Administration (FDA) has recently released two new guidance documents on artificial intelligence-enabled device software functions (AI-DSF): • “AI-enabled device…
Cornelia C. Walther
On April 8, 2025, a driverless Zoox robotaxi misjudged an approaching vehicle, braked too late, and sideswiped it at 43 mph on the Las Vegas Strip.
One month later, the Amazon subsidiary issued a software recall on 270 autonomous vehicles and suspended operations while regulators investigated the…
Heidi Drafall
Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.
The…
Jones Loflin
This past weekend I engaged in one of my favorite activities as a beekeeper. I got to catch a swarm of bees.
If you haven’t seen it before, it’s wild. About half of the bees leave with a queen and set up somewhere temporarily while they’re looking for their new permanent home. In the case of this…
William A. Levinson
According to the U.S. News & World Report article “FDA Warns Sanofi of Manufacturing Irregularities at Key Facility” (Jan. 23, 2025), the pharmaceutical company Sanofi received a U.S. Food and Drug Administration warning letter “stating that FDA inspectors found irregularities with the facility…
Bryan Christiansen
The cornerstone of efficient industrial and facility management, maintenance, repair, and operations (MRO) cover all activities related to equipment maintenance, procurement, upkeep, and inventory management. This includes spare parts, consumables, lubricants, cleaning supplies, safety equipment,…
Harish Jose
I am a longtime admirer of George Spencer-Brown’s “Laws of Form.” In this article, I explore how his notion of reentry helps illuminate the paradoxes and blind spots in modern ideologies, especially the rise of xenophobia and extreme nationalism. These rigid ideologies depend on distinctions…
Matt McFarlane
One of the key findings in Greenlight Guru’s 2025 Medical Device Industry Report was that economic uncertainty is playing a large role in the decisions medical device companies make this year.
The report surveyed more than 500 medical device professionals across quality, regulatory, product…
Stephanie Ojeda
Every day, quality leaders face a variety of production and process issues. Although some problems are easy to fix, others require deeper investigation, such as using a 5 Whys analysis or fishbone diagram. But then there are the stubborn, recurring issues that can lead to quality issues, increased…
ISO
Occupational health and safety (OHS) is often brushed aside as a checkbox exercise—something assigned to compliance officers or forgotten in day-to-day operations. But this mindset comes at a cost. Every year, millions of people suffer injuries, illnesses, or worse, simply because their workplace…
Stephen Graham, Quality Digest
Uploading something “to the cloud” has become common enough that most people are acutely aware of the storage advantages of cloud services—whether in their personal or professional lives—as well as how they might benefit administrators in any business. What might surprise people is the additional…
Colin Strachan
Most industrial leaders strive to be more proactive and data-driven. But getting there can feel overwhelming, especially if your teams spend much of the day firefighting.
Maintenance maturity depends on the quality of your data, how effectively you use them, and the processes and culture that…
Prerna Sudera
Ensuring that automotive components meet the highest quality standards is critical to vehicle safety and performance. Metals and protective coatings used in automotive manufacturing must withstand extreme conditions such as mechanical stresses, corrosion, and wear during a vehicle’s lifespan. Here…
CIH Equipment
Industrial hygiene equipment plays a critical role in ensuring workplace safety by monitoring airborne contaminants, noise levels, and other hazardous conditions. However, accurate readings depend on regular industrial hygiene equipment calibration to maintain precision and compliance with…
John O'Kelly
Warehouses are the backbone of supply chains, ensuring that goods move efficiently from suppliers to consumers. However, the physical demands of warehouse work—heavy lifting, repetitive motions, and prolonged standing—can take a toll on employees, leading to fatigue, injuries, and long-term strain…
Bryan Christiansen
Failure analysis helps uncover the root cause of equipment issues so you can fix problems and prevent them from happening again. This guide outlines a clear, six-step process to conduct effective failure analysis and write a report that adds long-term value.
Failure analysis techniques vary widely…
Kelley Jacobsen
As global trade uncertainty intensifies, health systems should take steps to minimize the effect of this volatility on their medical equipment inventory. The evolving policies of the United States and its trading partners could strain global supply chains and make acquiring or maintaining medical…
Etienne Nichols
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
Michael Mills
Risk-based thinking—it sounds easy. How hard can it be to think about risk? But did you know that the phrase “risk-based thinking” was only invented in 2015?
Did you know that the ISO says “risk-based thinking” is one of the foundations of quality management, but never defines it? Or that it…
Felipe Monteiro
Global risks are rising, and many companies are struggling to adapt. The World Economic Forum’s 2025 Global Risks Report makes it clear that challenges like escalating global tensions and conflicts, climate change, economic instability, and supply chain disruptions are interconnected and build on…
Jonathan R. Todd
Geopolitical risk is emerging as one of the greatest challenges facing domestic and international business today. It has risen from a boardroom issue to one drawing the awareness and attention of both personnel and the general public. These days everyone knows the word “supply chain” and has some…
Maria DiBari
This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…
Etienne Nichols
Have you ever wondered what your medtech company looks like from the point of view of a U.S. Food and Drug Administration investigator? Well, this is your chance to find out.
Greenlight Guru invited Vincent Cafiso, a former FDA investigator, to the Global Medical Device Podcast to share his…
Stephanie Ojeda
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820, and ICH Q10 in the pharmaceutical and biotech…
