Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
Full Service
Full Circle Consulting
EMMA OnDemand
Quality
Quality System Development
Quality System Implementation
Post Market Compliance
ISO Standards Consulting
Operations
Product Development
Manufacturing & Distribution
Regulatory
Regulatory Strategy
Regulatory Submissions
EU MDR and IVDR
Featured Services
Project Management
Staff Augmentation
Ready to learn more about working with us?
Full Circle Consulting Resources
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 ...
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