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I will do fda medical device registration and listing
rey ami
About this gig
I provide professional FDA medical device establishment registration and device listing support for manufacturers, specification developers, importers, and non-U.S. companies entering the U.S. market.
My Services Include:
- FDA Medical Device Registration
- FDA Establishment Registration
- Device classification & regulatory pathway review
- Device Listing & Product Code Identification
- 510(k) Documentation Support
- U.S. Agent Assistance
- UDI & GUDID Compliance Support
- Labeling & Regulatory Review
- FDA Compliance Consultation
Please message me before ordering
Get to know rey ami
rey ami
FDA EXPERT
- FromUnited States
- Member sinceAug 2026
- Avg. response time1 hour
Languages
English
I am a FDA Peptide website design expert and a licensed Clinical Psychologist (PhD) specializing in psychological reports, mental health evaluations, behavioral assessments, clinical documentation, counseling reports, and psychology case studies. I provide accurate, confidential, and professionally written mental health documentation tailored to clinical, academic, and professional needs with fast delivery and reliable communication.
FAQ
Do you handle FDA 510(k), PMA, and De Novo submissions?
Yes. I provide complete FDA 510(k) submissions, PMA applications, De Novo requests, and IDE filings, including technical documentation, regulatory strategy, risk analysis, and FDA response support.
Do you help startups and international companies get FDA approval?
Yes. I work with startups, manufacturers, and international medical device companies, providing end-to-end FDA regulatory consulting, U.S. market entry support, and FDA compliance documentation.
Can you prepare FDA documentation for medical software and telemedicine apps?
Absolutely. I specialize in Software as a Medical Device (SaMD), medical software FDA compliance, telemedicine app regulatory documentation, and digital health FDA submissions, including cybersecurity and software lifecycle files
Can you assist with FDA labeling, packaging, and UDI compliance?
Yes. I offer FDA labeling review, UDI compliance, medical device packaging validation, IFU development, and regulatory conformity checks.
