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I will support for eudamed module 2 udi,device listing registration
Arooj Zahid
Level 2
About this gig
Complete EUDAMED Module 2 (UDI/Device Registration) support for medical device manufacturers under EU MDR requirements.
Services include:
Basic UDI-DI assessment and registration support
UDI-DI data preparation and verification
EUDAMED Device Registration Module support
Medical device listing assistance
Device data validation and compliance review
MDR Article 29 registration guidance
Technical documentation review for registration readiness
EUDAMED data entry support
Registration troubleshooting and corrections
Post-registration regulatory support
This service is suitable for Class I, Class IIa, Class IIb, medical devices requiring EUDAMED registration before placement on the European market.
please contact me before placing of order.
Get to know Arooj Zahid
Arooj Zahid
Regulatory Compliance Consultant ISO, SOC 2, HIPAA, GDPR
Level 2
- FromPakistan
- Member sinceAug 2023
- Avg. response time1 hour
- Last delivery1 day
Languages
Urdu, English, Hindi, Chinese
Hi, I'm Arooj Zahid, Regulatory Compliance Consultant with 6+ years of experience helping businesses achieve international certifications and regulatory compliance at Precise GCS (Pvt.) Ltd. I specialize in ISO 9001, ISO 13485, ISO 27001, CE MDR, FDA, UKCA, MHRA, SOC 2, HIPAA, GDPR, Technical Documentation, QMS, ISMS, and Regulatory Compliance. I help businesses achieve international certifications, regulatory approvals, and compliance through accurate documentation and practical consulting.
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FAQ
What information do you need to start the EUDAMED registration process?
I will need the manufacturer details, device name, device classification, intended purpose, Basic UDI-DI (if available), UDI issuing entity information, and relevant technical documentation.
Can you help with Basic UDI-DI registration?
Yes. I provide support for Basic UDI-DI assessment, data preparation, and registration guidance according to EU MDR requirements before device listing in EUDAMED.
Does this service include device listing in EUDAMED Module 2?
Yes. I provide support for EUDAMED Module 2 (UDI/Device Registration), including device listing, data preparation, and compliance review.
