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EU Regulation Is Driving Medical Device Manufacturers From EU Market

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In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address.

The Research on Reducing Health Worker Burnout

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Emergency medical workers, already at increased risk for burnout compared to other professions, continue to be challenged by the fallout of Covid-19.

Handing the Surgeon’s Scalpel to a Robot

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Courtesy of Axel Krieger and Jin Yang

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In 2004, the United States’ Defense Advanced Research Projects Agency (DARPA) dangled a $1 million prize for any group that could design an autonomous car that could drive itself through 142 miles of rough terrain from Barstow, California, to Primm, Nevada.

Three Tips For Incorporating Risk Management During Medical Device Product Development

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Photo by National Cancer Institute on Unsplash.

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Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these two processes are related.

Migrating Your QMS From Paper to AI

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Every company wants to succeed, but not all can say they meet the current requirements to do that. More than a focus on capital, business plans, or staff, a successful business in 2022 must operate digitally.

Study Points to Ways to Cut US Healthcare Billing Costs

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AStanford Medicine-led study has found that borrowing certain billing- and insurance-related procedures from other countries could lead to policies that drastically lower healthcare costs in the U.S.

Using Machine Learning to Identify Undiagnosable Cancers

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Credit: National Cancer Institute on Unsplash
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The first step in choosing the appropriate treatment for a cancer patient is to identify their specific type of cancer, including determining the primary site: the organ or part of the body where the cancer begins.

Top Five Tips for Managing Workplace Hazards

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The workplace has changed forever, having gone through a revolution similar to the Industrial Revolution. Our workplaces are diverse, complex, and frequently changing.

Why Class 1 Medical Device Companies Need Design Control

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I know what you’re thinking. You’ve got a medical device prototype that the FDA has categorized as Class I. You’re ready to push forward to manufacturing or marketing the device, since there are no formal requirements for design controls.

A New Framework for Measuring Stability During Walking

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Photo by Chris Montgomery on Unsplash
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Falls are a serious public health issue that result in tens of thousands of deaths annually while racking up billions of dollars in healthcare costs.

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