Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert document forms and display medical device data. MDDS on its own does not modify the data or control any functions of the connected...
In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but nothing compares to the features and computing power enabled by Artificial Intelligence (AI). It is often utilized in cases of predictions, reducing...
Last week, the FDA published a safety communication on how the accuracy of pulse oximeters can be affected by skin pigmentation. Specifically, there were concerns that darker skin pigmentations can considerably affect the validity of results read from oximeters, both...
In this constantly changing world, it is important that your products keep up with the latest technology available. With medical devices now being in the form of wearables, long gone are the days when patients needed to be hooked up...
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use which are used as a tool to help users operate a medical device must also change and adapt. While using paper-based...
For any software development, there is a defined pattern. What I like to do is always start with the identification of the problem statement. The answer to this question forms the major purpose of the software. Then I like to...
If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it going back and just simply fixing non-compliances, is it a response to regulatory enforcement actions? The short answer is...
If you are a manufacturer of a radiation-emitting medical device, then 21CFR 820 is not the only regulation that you need to comply with. Title 21 of the Code of Federal Regulations, Parts 1000 through 1050 (21 CFR 1000 –...
EMMA International celebrates February in recognition of American Heart Association Month and we bring you an interesting blog on the 8 types of medical devices that perform heart-related element monitoring and essential actions in case of heart-related diseases. The first device...
While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing. Scientists at the Tel Aviv University, Israel, 3D printed the world’s first human heart using actual human tissues.1 I knew the basic definition...