All medical devices are regulated by the U.S. Food and Drug Administration (FDA).
CE Mark Medical has a working relationship with 510k FDA Consulting that has provided FDA regulatory services to international clients for more than 30 years. They have cleared petitions ranging from radiation generators, orthopedic external fixators, ophthalmic devices, medical imaging products, dental implants and abutments and CAD/CAM 3D printing devices.
The firm specializes in the preparation of 510(k)’s for Class I and II medical devices. Clients represent a broad range of domestic manufacturers, initial importers, and foreign manufacturers wanting to introduce new medical devices in the United States. The also provide services for foreign manufacturers as their U. S. Agents.
Contact 510k FDA Consulting and ask to speak with Joyce as she is one of their expert team members. You may reach her directly at email@example.com or 386-506-8711. She will answer any questions you might have about the process, and will assist you down the pathway to FDA approval of your new medical device. Then assist you through the registration process to bring your device into the U.S. marketplace.
Visit their website www.510kFDA.com for more information regarding timeframe and a cost indication.
For European support regarding 510K FDA use the following contact methods:
Telephone: +31 (0)294 41 75 81.