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I will do fda medical device registration, listing and 510k
James R
About this gig
Trying to sell your medical device in the US but stuck on FDA registration or 510k? One missed step can delay your launch by months or get your device flagged.
I help medical device companies get FDA registered, listed, and 510k-ready accurately, no regulatory guesswork.
What you get:
FDA medical device establishment registration
Device listing in the FDA database
510k submission preparation & documentation
US Agent appointment for device compliance
Compliance review against 21 CFR & ISO 13485
Why clients choose me:
100+ medical device registrations completed
Most registrations delivered within 48-72 hours
Zero rejected submissions handled
The real cost of getting this wrong: no registration means no legal US entry, no listing means no visibility, a weak 510k means months of delay and lost sales. I handle the regulatory groundwork so your device gets to market compliant and on schedule.
Launching a device and unsure where your FDA status stands? Don't wait for a rejection to find out.
Message me now let's get your device FDA registered and market-ready.
Get to know James R
James R
FDA Regulatory Compliance Specialist
- FromUnited States
- Member sinceSep 2026
- Avg. response time1 hour
Languages
English
I am an FDA Regulatory Compliance Specialist helping food, drug, cosmetic, and medical device companies get registered and market-ready. I have hands-on experience across facility registration, US Agent services, and label compliance. I focus on building compliance systems that resolve import holds and withstand scrutiny through a straightforward, jargon-free approach.
Other Regulatory Compliance Consulting Services I Offer
FAQ
What's included in FDA medical device registration?
Establishment registration with the FDA, device listing in the FDA database, and confirmation of your device's regulatory pathway (510k, PMA, or exempt).
Do you handle 510k submissions?
Yes I prepare and assist with 510k documentation and submission for devices that require premarket notification
Do I need a US Agent if I'm not based in the US?
Yes, FDA requires a US Agent for foreign device establishments. I offer this as part of the service.
How long does registration take?
Most establishment registrations and listings are completed within 48-72 hours. 510k preparation timelines depend on device complexity.
What device classes do you work with?
Class I, II, and III devices I'll confirm your device's classification and the correct regulatory pathway before starting.
