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January 12, 2022

ISO 10993-12:2021

Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

We all are aware that the 2021 version of the ISO 10993-12 has been released and there...

January 12, 2022

New Classification list for Medical Device

India is considered one of the leading worldwide medical device markets. Being in this position, India has made a significant change towards its device classification which made the regulatory p...

June 22, 2021

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...

June 15, 2021

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...

June 15, 2021

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...

June 15, 2021

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...

June 15, 2021

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...

June 15, 2021

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...

June 15, 2021

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...

June 3, 2021

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...