Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

International Women’s Day

International Women’s Day

March 8th is International Women’s Day. This day is set aside to celebrate the global social, economic, cultural, ...
What to Expect When You’re Inspected

What to Expect When You’re Inspected

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.
The FDA’s Action Plan for AI-ML-Based Software As A Medical Device

The FDA’s Action Plan for AI-ML-Based Software As A Medical Device

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.
Is Electronic-IFU an Option?

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
What is Remediation?

What is Remediation?

If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it ...

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