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Bingham Farms, MI, March 8, 2021 – E.M.M.A. International Consulting Group, Inc. (EMMA International), a global ...
Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert ...
In my software engineering career, I was lucky enough to work on some amazing frameworks and technologies, but ...
Last week, the FDA published a safety communication on how the accuracy of pulse oximeters can be affected by skin ...
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 ...
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