Etienne Nichols
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...
Chris Bush
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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...
Jennifer Chu
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...
NIST
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...
Lindsey Walker
In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological...
Etienne Nichols
On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR). The proposed QMSR will be the result of aligning the...
Etienne Nichols
Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be...
Aaron Smith
A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime. Uptime refers to your employees’ freedom to pursue personal...
Stephanie Ojeda
Design controls are a frequent citation in 483 observations and warning letters from the U.S. Food and Drug Administration (FDA). In fact, the agency has noted a large proportion of past recalls that...
Gleb Tsipursky
The unemployment rate is surprisingly low, at 3.7%, shocking economists who expected a slowdown in hiring and rising unemployment rate. Frontline work, such as healthcare, led job growth. Frontline...
Etienne Nichols
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your specifications.
But achieving that...
Stephanie Ojeda
Effective complaint handling is fundamental to life-sciences quality management, with implications for operations, product design, risk management, and more.
It’s also critical to ISO 9001, FDA...
Michael King
Medical companies work in an environment of ever-increasing challenge and complexity. Global regulations continue to evolve with advancements in technology and variations in requirements from country...
Mike Morini
Following the turmoil of the pandemic, many salaried employees have had the opportunity to work remotely and enjoy newfound flexibility in their day-to-day work lives. For many, the ability to be...
Silke von Gemmingen
Rigid endoscopes are used in medical diagnostics and therapy to examine body cavities and hollow organs, and to perform minimally invasive procedures. To avoid risks for patients and medical staff,...
Melissa Phillips
The levels of contaminants in our food supply are, generally, decreasing. That’s the good news.
But we still need to measure those contaminants and make sure our food is safe. And measuring tiny...
Etienne Nichols
Medical device companies must have established risk management processes that comply with ISO 14971. It doesn’t matter whether you’re developing medical devices in the U.S., EU, Canada, or elsewhere...
Ophir Ronen
From the health histories of patients to the effectiveness of different healthcare services, hospitals are sitting on a treasure trove of historical data. Unfortunately, most of these data go unused...
Martin Cottam
It’s tempting to attribute the increased profile now given to occupational health and safety (OH&S) to the Covid-19 pandemic. But while in many organizations the pandemic shone a spotlight on OH...
Matthew M. Lowe
Change of any kind often requires a catalyst. This is particularly true in a business environment where the rule of thumb is to do things the way they’ve always been done. And when you’re working in...
