Medical Device

A Guide to Medical Device Risk Management & ISO 14971

Medical device risk management is rightfully an essential component of medical product design and development. When it comes to putting a product on the market, risk analysis is required by law, and regulation checklists must be followed thoroughly. These regulations are carefully outlined in ISO 14971 to...

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How Prototype Tooling Can Be a Smarter Alternative to Production Tooling

Tool selection is important to the medical device design and development and manufacturing processes, one that can make or break a project, and it’s not a cut-and-dry decision. There are actually three different types of tooling: prototype tooling, bridge tooling, and production tooling. Each type has its...

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The Importance of Proper Medical Device Labeling

What Is Medical Device Labeling? Medical device labeling refers to all of the information that is provided to the consumer with the device itself. This includes symbols, warnings, instructions, and control labels applied to the device or incorporated into the design by color coding, printing, machining, or...

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Medical Device Design UX Workflow

UX workflows for medical devices are changing the healthcare industry. Adhering to a workflow that is user-focused is critical to maintaining this level of healthcare innovation. So what should a UX design workflow include, and how can designers keep users at the forefront? Let’s walk through how...

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623 Medical Announces the Launch of Nüm, a Novel Sterile Topical Anesthetic Spray

MORRISVILLE, N.C., June 1, 2021 - 623 Medical has announced that their first commercial product, nüm, has been cleared by the FDA and is now available for sale in the US market. Nüm is a sterile topical anesthetic spray used to numb the skin prior to needle...

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Yukon Medical Granted Formal Approval to Sell ClearTip™ Swabs in the European Union

DURHAM, N.C., May 18, 2021 - Durham-based medical device company Yukon Medical announced today that it has been granted formal approval to sell ClearTip™ swabs (specimen collection devices) in the European Union. The announcement comes four months after the domestic listing of ClearTip swabs with the US...

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How the Internet of Medical Things (IoMT) is Changing Healthcare

You may have heard of the Internet of Things (IoT) and how it helps to connect and power our lives, from fitness trackers to traffic lights to the ability to turn on our home security systems from anywhere. The Internet of Medical Things (IoMT) is having just...

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Understanding Human-Centered Design

“If you think good design is expensive, you should look at the cost of bad design,” said Dr. Ralf Speth, CEO of Jaguar Land Rover. While the medical device industry is not the same as the automobile industry, the sentiment still applies. Not only can a bad...

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Connected Medical Devices: The Rise of Smart Health Solutions

Innovation is a hallmark of the medtech industry. As connected technology becomes more intertwined in our daily lives, it only makes sense that more medical products capable of internet connectivity will enter the market. The number of connected medical devices in the market is expected to increase...

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The Difference Between Medical Device Quality Control & Quality Assurance

The last thing a medical device manufacturer wants is for a piece of equipment to malfunction once it gets into the hands of a clinician, patient or caregiver. With such high stakes, the emphasis on quality when it comes to this form of design and manufacturing is...

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