The recent trend of U.S. Food and Drug Association citations issued to those operating in the pharmaceutical...
Quality Systems
ISO 13485 & QSR Harmonization
For several years there has been quite the buzz in the Med Device Industry about the potential harmonization between...
Western Lifestyle Increases COVID-19 Severity
Researchers in the United States have developed an experimental infection model of the Syrian hamsters that were fed a...
Quality Management Systems that CLIC™
While a Quality Management System (QMS) is a necessary and foundational element of any life-science...
Digital Health: The New Wave of Medicine
New digital health technology is coming out every day and is changing the course of the MedTech industry as we know...
Using QFD for Medical Device Development
Quality Function Deployment, or QFD, is a decades-old methodology focused on the voice of the customer. It was...
5 Things To Consider When Making A Change To An Existing Medical Device
In this constantly changing world, it is important that your products keep up with the latest technology available....
Is Electronic-IFU an Option?
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use...
The Do’s and Don’ts for Medical Software Development
For any software development, there is a defined pattern. What I like to do is always start with the identification of...
Caption Guidance – FDA’s First Authorized AI-Based Cardiac Ultrasound Software
Happy American Heart Association month, everyone! While celebrating this month at EMMA International, we bring you...
Prioritizing Cybersecurity in the Med Device Industry
The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health...
Mobile Applications for Heart and Blood Pressure Monitoring
Nowadays, there are mobile applications for almost every utility and in every domain. From e-commerce, finance,...
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