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…
Read articleNew 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…
Read articleModernization 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,…
Read articleIs 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 articleVirtual 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…
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…
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