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Repeat Solutions Circle
Repeat Solutions Circle

Ehab Amen

Director of Certification
GMED North America

Ehab Amen is the North America Director of Certification at GMED, a leading Notified Body designated under the EU MDR and IVDR, with over 16 years of experience in medical device certification, regulatory compliance, and quality management systems.
At GMED, Ehab oversees certification activities in the U.S. and supports manufacturers worldwide as they transition to MDR and IVDR. He emphasizes practical approaches to help organizations meet regulatory requirements and achieve timely CE marking, ensuring both compliance and continued market access.
His focus is on developing solutions that balance rigor with efficiency, working closely with companies of all sizes—from startups to multinationals—and guiding them through complex conformity assessment processes while minimizing disruption to business operations. He advocates transparency, predictability, and harmonization of regulatory frameworks to help clients manage global obligations more effectively.

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