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I will provide fda medical device registration and device listing support
NORA DONNE
About this gig
FDA MEDICAL DEVICE REGISTRATION AND DEVICE LISTING SUPPORT
Are you looking for professional support with FDA medical device establishment registration and device listing? You are in the right place.
I provide regulatory support to medical device manufacturers, specification developers, importers, private label companies, startups, and international businesses preparing to enter the U.S. market.
MY SERVICES INCLUDE:
- FDA Establishment Registration Support
- Medical Device Listing Support
- Device Classification Review
- Regulatory Pathway
- FDA Account and Submission Support
- DUNS Number
- U.S. Agent Requirement
- UDI and GUDID Support
- 510(k) Regulatory Pathway
- FDA Compliance Documentation Review
This service is ideal for U.S. and foreign medical device companies seeking organized support with applicable FDA registration and listing requirements.
Every device may have different requirements depending on its classification, intended use, manufacturer location, and regulatory pathway.
Please message me before ordering with your device name, intended use, manufacturer location, and current FDA status so I can recommend the most suitable service.
Get to know NORA DONNE
NORA DONNE
FDA Medical Device Regulatory Compliance Specialist
- FromCanada
- Member sinceSep 2026
- Avg. response time1 hour
Languages
English, Spanish, French, German
I am a regulatory compliance professional specializing in medical device regulatory support and market access requirements. I help medical device manufacturers, importers, startups, and international companies with FDA establishment registration, medical device listing, classification review, regulatory pathway guidance, UDI/GUDID support, documentation review, and FDA compliance requirements. I provide clear communication, organized documentation, and practical support tailored to your device and regulatory needs.
FAQ
Can you help me register my medical device with the FDA?
Yes. I provide professional support with FDA establishment registration and medical device listing requirements based on the information you provide and the applicable regulatory pathway.
Can you help foreign manufacturers?
Yes. I support international medical device manufacturers and provide guidance regarding applicable U.S. registration requirements and U.S. Agent requirements.
Do you register Class I, Class II, and Class III medical devices?
I can review your device information and provide regulatory pathway guidance. Additional premarket requirements may apply depending on the device classification and intended use.
Do you provide 510(k) services?
I can provide 510(k) regulatory pathway guidance and support related to documentation requirements. Full 510(k) preparation may require a separate custom order.
Can you help with FDA device classification?
Yes. I can review your device information and provide guidance to help identify the applicable FDA classification and regulatory pathway.
Can you help with UDI and GUDID?
Yes. I provide guidance and support related to UDI and GUDID requirements.
Do I need a U.S. Agent?
Foreign medical device manufacturers may have U.S. Agent requirements. I can provide support based on your manufacturer location and applicable FDA requirements.
