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Unlike the traditional engineering process of designing a part, product, or component from the ground up, many times in life we need to start with an existing item and work backward to solve a problem. It’s a process known as reverse engineering, and it begins by obtaining accurate data about the…
Your legal department is screwing up. Royally.
You work hard to build relationships with other businesses. How many hours do you invest getting closer to partners, customers, and suppliers? And then that wonderful handshake happens, and it’s time to hammer out the agreements. That’s when Larry the…
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…
When it comes to customer service, few companies do it better than the UPS Store, Chick-fil-A, and REI.
That’s not according to me. That’s according to a recently published Best Customer Service list, which was compiled in a partnership between Forbes and HundredX, a data analytics company focused…
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…
Although a fix-it-the-first-time approach may be the gold standard of customer service, addressing potential issues before they materialize is the true mark of an exemplary user experience.
Consider the pace of our modern world: Customers today want instant solutions, and any hurdle might be a…
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…
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…
Cars are no longer just a means of transportation. They have become rolling hubs of data communication. Modern vehicles regularly transmit information wirelessly to their manufacturers.
However, as cars grow “smarter,” the right to repair them is under siege.
As legal scholars, we find that the…
Cars are no longer just a means of transportation. They have become rolling hubs of data communication. Modern vehicles regularly transmit information wirelessly to their manufacturers.
However, as cars grow “smarter,” the right to repair them is under siege.
As legal scholars, we find that the…
Amazon’s incredible growth over the years has made it a textbook example of what it means for a business to scale, going from a scrappy startup in Jeff Bezos’ garage to a multinational corporation with more than 1.5 million employees.
The retailer recently announced it’s hiring 250,000 full- and…
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…
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…
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…
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…
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…
I’m going to take over the world! It’s really fun to say that. It’s even more fun to take action toward that goal.
Our world has gotten smaller. Way smaller. Globalization is an unstoppable trend. But as they say, the trend is your friend, so why not take advantage of it? I don’t care how big or…
“I don’t understand. This hotel has no restaurant, no concierge, and no valet. It’s not at all what I expected. The place had no standards.”—Guest at a roadside motel
“I showed her the picture of Jennifer Aniston and asked for the same haircut. She cut my hair, but I still don’t look a thing like…
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…
In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders. Amid supply chain disruptions during the pandemic, hospitals scrambled to find enough devices to keep up with unprecedented demand. The global crisis revealed gaps in standard…
Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.
But as anyone in the industry can tell you, consistently getting the products and services you need to manufacture your devices is harder than it sounds. In…
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The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the U.S. and the EU have regulations in place that govern the collection, storage, and use of patient data in healthcare.
In the U.S., there is the…
Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination. And in most cases, the wait time has to do with time-consuming steps in sample processing and analysis.
Now, MIT engineers…
Magnetic resonance imaging (MRI) machines can clearly view non-bony parts of the body—soft tissue such as the brain, muscles, and ligaments—as well as detect tumors, making it possible to diagnose many diseases and other conditions. However, the powerful magnets in conventional MRI machines make…
Let’s start with a definition of Industry 4.0, keeping in mind that we’re rapidly approaching Industry 5.0. Industry 4.0 is an era marked by enhanced digitization and the increased connectivity of smart technologies. Where Industry 5.0 is more values-driven, it will require the technology of…