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I will prepare fda medical device premarket submissions and 510k documentation
Bridging the Gap Between Innovation and Global Medical Compliance
Dedicated Medical Compliance Specialist with a focus on ISO 13485 and EU MDR/FDA frameworks. I help medical device manufacturers navigate complex regulatory landscapes through robust QMS documentation...
About this Gig
Need expert support with FDA medical device, 510(k) documentation, and FDA regulatory compliance?
I help medical device manufacturers, startups, and healthcare companies prepare accurate technical documentation and navigate the FDA approval process with confidence.
Whether you're seeking FDA facility registration, device listing, or a complete 510(k) dossier, I deliver organized regulatory documentation tailored to your product and compliance requirements.
Services Include:
- FDA Medical Device Registration
- 510(k) Dossier & Technical Documentation
- FDA Facility Registration & Device Listing
- Device Classification & Predicate Research
- GUDID & DUNS/UFI Guidance
- ISO 13485 QMS Documentation
- Risk Management & FDA Label Review
- FDA US Agent & Regulatory Consulting
Every project is prepared with accuracy, attention to regulatory requirements, and a focus on helping you achieve a smoother FDA review process while minimizing compliance risks.
Contact me today to discuss your medical device project and receive professional FDA regulatory support.
FAQ
What is included in your FDA 510(k) submission service?
My 510k submission service is a comprehensive regulatory affairs solution. It includes predicate device identification, "substantial equivalence" analysis, and full 510k dossier preparation. As an ISO 13485 expert, I ensure all technical documentation and risk management files meet FDA compliance st
Can you help with FDA registration and device listing?
Yes. I manage the entire FDA registration process, including facility registration and device listing for Class I, II, and III products. I also assist in obtaining your DUNS/UFI number and ensuring your GUDID (Unique Device Identification) entries are accurate and compliant with the latest medical d
Do you provide US Agent services for foreign manufacturers?
Absolutely. I act as a professional FDA US Agent for international companies seeking USA market entry. This includes handling communications with the FDA, assisting in import permit queries, and ensuring your food facility or medical device establishment remains in good standing during annual renewa
How do you handle MoCRA and cosmetic product compliance?
With the implementation of MoCRA, cosmetics brands now face stricter FDA compliance rules. I provide product listing, label review, and adverse event reporting setup. I ensure your cosmetic manufacturing facility meets the new FDA registration mandates to avoid shipment holds.
Can you assist with NDC codes and drug establishment registration?
Yes. For drugs and nutraceuticals, I handle drug establishment registration and the acquisition of NDC codes (National Drug Code). I also perform a thorough label review to ensure your packaging meets FDA requirements for over-the-counter (OTC) or prescription products.
Do you support UKCA, MHRA, and CE Marking (EU MDR)?
Yes. My expertise extends beyond the USA. I provide technical file preparation for CE marking under the EU MDR, as well as UKCA and MHRA registrations for the UK market. This ensures a synchronized global regulatory strategy for your medical devices.
Why is a Pre-Submission (Pre-Sub) important for my medical device?
A pre-submission (Q-Submission) allows us to get direct feedback from the FDA on your 510k dossier strategy. This reduces the risk of an "Additional Information" request, streamlines your 510k submission timeline, and ensures your clinical data meets the reviewer's expectations.
What is your experience with ISO 13485 and QMS auditing?
I am an IRCA-approved Lead Auditor for ISO 13485:2016 and ISO 9001:2015. I specialize in building "audit-ready" QMS (Quality Management Systems), conducting internal audit sessions, and preparing companies for ISO certification or FDA QSIT inspections.
