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))…
Read article3D 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…
Read articleAre 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…
Read articleSafety 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…
Read articleFunding 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…
Read articlePostmarket 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.…
Read articleProduct Development
Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena…
Read articleAddressing 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…
Read articleAccess 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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