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In this webinar hosted from EMMA International's Manager of Technical Operations, Madison Wheeler, she gives a walkthrough of what to expect from an FDA inspection of your facility, plus the "do's and don'ts" of regulatory inspections.
In this webinar hosted from EMMA International's Software Engineer, Govind Yatnalkar, he focuses on the recently released FDA's action plan for regulating AI/ML-based software as a medical device (SaMD). He then dives into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs.
In this constantly changing world, it is important that your products keep up with the latest technology available.
As we progress through the 4th Industrial Revolution, technology is advancing quicker and quicker. More and more ...
Changes in technology call for changes in the ways we use that technology. This means that the instructions for use
For any software development, there is a defined pattern. What I like to do is always start with the identification
If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it ...
If you are a manufacturer of a radiation-emitting medical device, then 21CFR 820 is not the only regulation that ...
EMMA International celebrates February in recognition of American Heart Association Month and we bring you an ...
While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing. ...
Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the ...
Happy American Heart Association month, everyone! While celebrating this month at EMMA International, we bring you ...
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