Browse categories
Explore
Fiverr Pro
English
$
USD
I will do fda preparation reviewing and submissions
Maryam
Level 2
1 order in queue
5.0
5.0
Gig Summary
About this gig
**FDA 510(k) Submission Services**
Struggling with the FDA 510(k) submission process? I help medical device manufacturers achieve FDA clearance efficiently.
Services:
- **510(k) Preparation:** Comprehensive support to meet FDA requirements
- **Documentation Review:** Review of technical documentation
- **Predicate Device Identification:** Analysis to strengthen submission
- **Regulatory Strategy:** Clear strategy for the FDA process
- **FDA Communication:** Liaison with the FDA
- **Post-Submission Support:** Assistance with FDA feedback
Why Choose Me?
- **Expertise:** 15 years in FDA regulations
- **Proven Track Record:** Successfully helped numerous
- **Tailored Support:** Customized solutions
- **Time-Saving:** Streamlined process
- **Affordable:** Cost-effective services
Who Is This For?
- Medical device manufacturers seeking FDA clearance
- Companies new to the 510(k) process
- Startups and SMEs needing regulatory support
- Manufacturers updating legacy devices
Steps:
- Contact Me: Share details
- Plan: Strategy session
- Prep: Application preparation
- Submit: Manage FDA communication
- Clearance: Market access!
Ready for FDA clearance? Contact me today!
Get to know Maryam
Maryam
Certified Regulatory Affairs Professional for Medical Industry
Level 2
- FromUnited States
- Member sinceJul 2024
- Avg. response time1 hour
- Last delivery3 weeks
Languages
English
Medical Device Regulatory & Quality Compliance Expert specializing in EU MDR 2017/745, IVDR, CE Marking, UKCA, MHRA, FDA 21 CFR 820/QMSR, FDA 510(k), PMA, De Novo, ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 10993, ISO 15223-1, ISO 20417, ISO 11135, ISO 11137, MDSAP, Health Canada, TGA, SFDA, MOHAP, NMPA, PMDA, CDSCO, EUDAMED, UDI, GSPR, CER, CEP, PER, PMS, PMCF, PSUR, Clinical & Performance Evaluation, Technical Documentation, Design Dossier, Risk Management, Usability Engineering, Biocompatibility, Sterilization, QMS, Internal Audits, Global Regulatory Submissions & Market Access
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Q: What is a 510(k) submission?
A: A 510(k) is a premarket submission to the FDA to demonstrate that your device is safe, effective, and substantially equivalent to a legally marketed predicate device.
Q: How long does the 510(k) process take?
A: The FDA typically reviews 510(k) submissions within 90 days, but preparation and response to queries can extend the timeline.
Q: Can you help with complex devices?
A: Yes, I have experience with a wide range of devices, including Class II and some Class III devices.
Q: Do you work with startups?
A: Absolutely! I offer tailored solutions for startups and SMEs to make the process affordable and efficient.
Q: What documents do I need to provide?
A: You’ll need to share device specifications, testing data, labeling, and other technical documentation. I’ll guide you through the process.
Reviews
11 reviews for this Gig
| (11) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
E elisacardenas
Saudi Arabia
She is very knowledgeable and will definitely put you on the right track when dealing with the FDA, which is not an easy organization. She is my go to person now for all FDA matters
Up to $50
Price
2 weeks
Duration
Helpful?R 
rickardpetter
United States
Absolutely brilliant! The seller provided expert-level work with incredible creativity and precision. The final result is beyond amazing
Up to $50
Price
2 days
Duration
Helpful?N 
novellereva
United States
The seller was easy to work with and delivered exactly as promised. The quality of work was top-notch, and I’m very satisfied. Will definitely recommend!
Up to $50
Price
1 day
Duration
Helpful?H hadriangideon
United States
he seller followed my instructions precisely and kept me updated throughout the process.
Up to $50
Price
2 days
Duration
Helpful?F faelorio
United States
The seller provided excellent service and delivered high-quality work on time. Will hire them again.
Up to $50
Price
2 days
Duration
Helpful?
Reviews
11 reviews for this Gig
| (11) | ||
| (0) | ||
| (0) | ||
| (0) | ||
| (0) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
E elisacardenas
Saudi Arabia
She is very knowledgeable and will definitely put you on the right track when dealing with the FDA, which is not an easy organization. She is my go to person now for all FDA matters
Up to $50
Price
2 weeks
Duration
Helpful?R rickardpetter
United States
Absolutely brilliant! The seller provided expert-level work with incredible creativity and precision. The final result is beyond amazing
Up to $50
Price
2 days
Duration
Helpful?N novellereva
United States
The seller was easy to work with and delivered exactly as promised. The quality of work was top-notch, and I’m very satisfied. Will definitely recommend!
Up to $50
Price
1 day
Duration
Helpful?H hadriangideon
United States
he seller followed my instructions precisely and kept me updated throughout the process.
Up to $50
Price
2 days
Duration
Helpful?F faelorio
United States
The seller provided excellent service and delivered high-quality work on time. Will hire them again.
Up to $50
Price
2 days
Duration
Helpful?
