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I will do fda medical device registration and listing
Dorcas F.
About this gig
Need to register your medical device with the U.S. FDA?
I offer end-to-end consulting for FDA medical device facility registration and device listing, helping domestic and international medical device brands enter the U.S. market seamlessly.
With extensive experience in quality management systems and regulatory strategy, I provide accurate, step-by-step guidance to ensure your products fully meet U.S. regulatory standards.
What I Can Help You With:
- FDA Establishment Registration
- Product & Medical Device Listing
- DUNS & Unique Facility Identifier (UFI) Support
- Device Risk Classification & Pathway Strategy
- FDA account/submission support
- FDA U.S. Agent
- GUDID & UDI Compliance Setup
- 510(k) Premarket Advisory
- Documentation Review & Audit
Why Choose My Services?
- Expertise in FDA & ISO 13485 standards
- Tailored regulatory advisory
- Clear, transparent communication
- High-quality, submission-ready documentation
Please send a message before placing an order. Share your device details, business location, and current regulatory status so I can recommend the exact package for your needs.
Thanks.
Get to know Dorcas F.
Dorcas F.
FDA Registration Expert, MoCRA, Cosmetic, Medical Device Compliance Specialist
- FromNigeria
- Member sinceOct 2026
- Avg. response time1 hour
Languages
English
Hi, I’m Dorcas, an FDA regulatory and compliance specialist helping cosmetic, medical device, and healthcare businesses navigate FDA requirements with confidence. I provide professional support for MoCRA cosmetic registration, product listing, facility registration, medical device registration & listing, U.S. Agent services, GUDID/UDI, 510(k) support, and regulatory documentation. My goal is to make the process clear, accurate, and stress-free while helping your business stay properly positioned for the U.S. market. Feel free to message me before ordering so we can discuss your specific needs.
FAQ
Can you register a medical device with the FDA?
Yes. I provide expert FDA establishment registration, medical device listing, and compliance support for Class I, II, and III products to ensure complete adherence to U.S. FDA regulatory requirements and market access guidelines tailored to your specific product needs.
Do you support non-U.S. manufacturers?
Yes. I assist non-U.S. medical device manufacturers with FDA establishment registration, medical device listing, U.S. Agent coordination, and full FDA regulatory compliance solutions designed for seamless U.S. market expansion and entry.
Do you register Class I, II and III devices?
Yes. I evaluate medical device classification, regulatory pathways, 510(k) requirements, and FDA compliance guidelines to ensure complete medical device listing and establishment registration support across Class I, Class II, and Class III medical devices.
Do you provide 510(k) services?
Yes. I provide complete 510(k) regulatory pathway guidance, device classification analysis, premarket notification strategy, and custom documentation support alongside standard FDA medical device establishment registration and device listing services.
Do you provide DUNS registration support?
Yes. I provide step-by-step guidance for DUNS number registration, UFI validation, and official FDA account creation to complete your medical device establishment registration and FDA listing process smoothly and efficiently.
Can you help with GUDID/UDI?
Can you help with GUDID/UDI? Yes. I offer complete GUDID database account setup, Unique Device Identification (UDI) compliance guidance, and full listing verification support for medical device manufacturers seeking FDA registration compliance.
Do you provide U.S. Agent services?
I provide guidance and coordination regarding official U.S. Agent requirements, helping foreign medical device manufacturers connect with official U.S. Agent representation to achieve full FDA registration and device listing compliance.
How long does FDA registration take?
Timeline depends on device classification, FDA fee processing, establishment requirements, U.S. Agent response, and document readiness. I ensure efficient submission for your FDA establishment registration and medical device listing needs.
What information do you need to start?
Please provide manufacturer details, intended use, medical device classification, product specifications, current FDA status, DUNS number, and U.S. Agent details to initiate your FDA registration and device listing support services.
