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I will fda 510k submission documentation and US agent service for medical device
Kendra Tabhitha
About this gig
FDA 510(k) Submission & US Agent Service Expert Regulatory Support for US Market Entry
Bringing a medical device to the United States?
If your device is Class II, you likely require FDA 510(k) premarket notification clearance before legal distribution.
If you are a foreign manufacturer, you are also legally required to appoint a US Agent.
This is not paperwork.
This is regulatory strategy.
I provide structured, professional FDA 510(k) submission support and official US Agent service to help medical device companies enter the US market with clarity and confidence.
Get to know Kendra Tabhitha
Kendra Tabhitha
Your Trusted Partner for Regulatory Compliance and Quality Management
- FromUnited Kingdom
- Member sinceFeb 2026
- Avg. response time4 hours
Languages
English, Russian
I am a Regulatory Compliance and Quality Management Specialist with over 4 years of experience helping businesses achieve ISO certification, medical device compliance, and regulatory readiness. I specialize in ISO standards, MDR, ISO 13485, IEC 60601, compliance documentation, audit support, and quality management systems. My focus is delivering accurate, professional, and results-driven solutions that help organizations meet regulatory requirements with confidence.
Other Regulatory Compliance Consulting Services I Offer
FAQ
What is FDA 510(k) submission?
FDA 510(k) is a premarket notification required for most Class II medical devices to demonstrate substantial equivalence before US market approval.
Who needs a US Agent?
Foreign medical device manufacturers selling in the United States must appoint an FDA US Agent for official FDA communication.
Do you guarantee FDA clearance?
I ensure compliant and structured 510(k) preparation. Final clearance decisions are made by the FDA.
Do you support eSTAR submissions?
Yes. I provide guidance aligned with FDA eSTAR electronic submission requirements.
Can you help respond to FDA AI requests?
Yes, I assist with Additional Information (AI) response preparation.
