Is your medical device exempt?
Have you: In all the above scenarios, you need to ascertain whether your medical device is exempt, i.e., an FDA review (510(k))…
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3D Imaging Software – The Vision of Medicine
“Any sufficiently advanced technology is indistinguishable from magic.” Arthur C. Clarke’s Third Law, Profiles of the Future, 1973. Are you aware that…
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Are you designing to meet your customer needs?
Design is a funny word. Some people think design means how it looks. But of course, if you dig deeper, it’s really…
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Safety Concerns of Raw Milk Cheese
Have you ever wondered if the cheese you eat is pasteurized? With increasing consumer awareness, a modern consumer demands to be informed…
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Funding Trends – Medical Device Industry
The incessant growth in innovation and novel technologies has made the medical device industry the largest in healthcare. The US medical device…
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Postmarket Surveillance: An inescapable sound of noise
Are you a Medical Device Manufacturer? an employee of a medical device company? Or perhaps someone with an interest in Medical Devices.…
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Product Development
Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena…
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Addressing Duodenoscope contamination – An FDA Initiative
While reusable devices significantly help in cost-cutting and optimization of hospital supplies; cross-contamination is a prevalent problem with these devices. Regulatory bodies…
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Access to De Novo Summaries – A treasure for manufacturers
The De Novo pathway by the US Food and Drug Administration (FDA), is a risk-based classification process to classify novel medical devices…
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