Modernization of 510(k) – A major milestone to safer and better healthcare

More than 190,000 distinct medical devices are regulated by the FDA. Data from the years 2017 & 2018 indicates that about 3000, on average, low and moderate-risk medical devices received FDA...

Is your medical device exempt?

Have you:

Developed a novel medical device?Developed a medical device similar to or better than the ones existing in the market?Modified or changed the intended use of the device?Expanded...

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 in today’s world you can visualize the openi...

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 how it works.- Steve Jobs

As the quote goes, when designing a prod...

Virtual Vital Signs—the Invasion of Medical Devices to our Living Rooms

In the recent years healthcare has significantly advanced with the development of mobile based medical apps. Such apps have facilitated communication amongst doctors, hospitals, medical insuranc...

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 of dairy products that have not been subjected to pasteu...

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 industry is the global leader with sales of around...

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. If yes, then postmarket surveillance is something critical...

Product Development

Many companies treat product development as if it is equivalent to manufacturing. In reality, the two are tremendously different. In the arena of manufacturing physical objects, activities are r...

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 across the world...