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$
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I will complete fda gudid registration for medical devices
Naveed A
Level 2
About this gig
Need professional support with FDA GUDID registration for your medical device?
I provide regulatory support for preparing, reviewing, and submitting device information to the FDA Global Unique Device Identification Database (GUDID).
My service includes:
- GUDID requirements assessment
- Device Identifier (DI) information review
- Device and packaging data review
- GUDID data preparation and entry support
- UDI data consistency checks
- Identification of missing or incorrect information
- Submission and correction support
- Guidance for maintaining accurate device data
I support medical device manufacturers, private-label companies, importers, and regulatory teams with accurate and consistent GUDID information.
If you already have a GUDID record, I can also review the available information and help identify discrepancies or required updates.
Please note: This gig focuses specifically on GUDID/UDI data and does not replace FDA establishment registration, device listing, 510(k), De Novo, PMA, or other applicable FDA requirements.
Contact me before ordering if you have multiple devices, models, configurations, or packaging levels so I can recommend the appropriate package.
Get to know Naveed A
Naveed A
Medical Device Regulatory and QMS Consultant
Level 2
- FromPakistan
- Member sinceNov 2022
- Avg. response time1 hour
- Last delivery3 weeks
Languages
Urdu, English
Medical Device Regulatory and QMS Consultant with 20+ years of experience. I support medical device companies with FDA registration and listing, 510(k), EU MDR, UKCA, ISO 13485 QMS, ISO 14971 risk management, technical documentation, risk files, CER, IFU, SOPs, validation, CAPA, SCAR, audits, and regulatory compliance. I deliver practical, accurate, and audit-ready documentation tailored to your product, regulatory pathway, and business needs.
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FAQ
Q1: What is GUDID?
GUDID is the FDA's Global Unique Device Identification Database containing key identification information for medical devices that are required to have a UDI.
Q2: Do you provide GUDID registration support?
Yes. I can review the required information, identify missing data, prepare GUDID information, and provide submission/correction support.
Q3: Can you handle multiple devices?
Yes. Please contact me before ordering if you have multiple devices, models, configurations, or packaging levels so I can recommend the appropriate package.
Q4: Do you also provide FDA establishment registration?
Yes. I have a separate Fiverr service specifically for FDA establishment registration and medical device listing. This GUDID gig focuses specifically on GUDID/UDI data.
Q5: Can you correct an existing GUDID record?
Yes. I can review the available information, identify discrepancies, and provide support for correcting or updating applicable GUDID data.
Q6: Do I need a UDI before GUDID submission?
UDI/GUDID requirements depend on the device and applicable FDA requirements. I can review your device information and guide you on the applicable data elements and process.
