Register and List Your Medical Device with the FDA

Register and List Your Medical Device with the FDA

FDA's Role: The U.S. FDA is a regulatory body that maintains compliance standards for the safety and proper functioning of medical devices sold in the United States. Their function is safeguarding the public health and allowing individuals to be able to trust the items they use daily. Prior to the sale of the medical devices, […]

ACTOR REGISTRATION IN EUDAMED

Economic operators registering on the EUDAMED portal to obtain Single Registration Numbers (SRN) for EU medical device compliance

EUDAMED Update Alert: v2.18.1 is now live! The European Commission has deployed EUDAMED v2.18.1 on Dec 17, 2025. Key takeaway: No changes to XSD schemas, the version remains 3.0.22.1. For full release notes and documentation, check out the Information Centre The Implementing Act has been officially published in the Official Journal as of 27 November […]

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