I will perform fda registration for your medical device

R
rajzaveri
R
rajzaveri
Raj Z
perform fda registration for your medical device
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perform fda registration for your medical device

About this gig

Get your medical device facility FDA-Registered & listed in record time without the compliance headaches.

Are you a medical device manufacturer, repackager, or relabeler looking to legally market in the U.S.? Navigating FURLS, DRLM, and User Fee payments (MDUFA) can be tricky. One wrong classification can delay your imports or trigger FDA holds.

I handle the entire FDA Establishment Registration and Device Listing process accurately so you can focus on shipping products.

What I do for you:

  • FDA Establishment Registration: Account setup, official correspondent assignment, and registration via FURLS.
  • Device Listing (DRLM): Proper assignment of 510(k), PMA, or exempt product codes and listing numbers.
  • MDUFA Payment Walkthrough: Step-by-step guidance on paying your annual FDA user fee directly to the agency.

Why work with me?

  • Deep familiarity with FDA 21 CFR regulations.
  • Direct, transparent communication with zero generic templates.

Get to know Raj Z

Raj Z

Medical Device QARA consultant

5.0(4)
  • FromIndia
  • Member sinceJun 2023
  • Last delivery1 year

  • Languages

    English
Detail-oriented Quality and Regulatory Affairs professional with more than seven years of experience in US FDA, CE, TFDA (Thai FDA) and UKCA regulatory submissions for medical devices. Expertise in: 1. Premarket Notification (510(k)) 2. Presubmissions 3. EU regulatory submissions (Technical File and CER) as per the MDR 4. Setting up Quality Management System as per ISO 13485 and CFR 820 5. Establishing a sound Risk Management System as per ISO 14971 6. Creating and implementing SDLC documents as per IEC 62304

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