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I will do eudamed actor registration, srn and udi device registration
Komal Razzaq
Level 2
About this gig
Need to register your company or medical devices on EUDAMED? I provide complete EUDAMED registration support for EU and non-EU companies under EU MDR / IVDR.
My Services:
Actor Registration (SRN)
- Manufacturer, Importer, EC REP & System Producer
- Application preparation & submission
- Follow-up until SRN is issued
UDI/Device Registration
- Basic UDI-DI & UDI-DI data entry
- Device data upload
- Certificate & Notified Body linking
Non-EU Manufacturers
Provides EU Authorized Representative Services.
Why Work With Me?
- Accurate EUDAMED data entry
- Class I to Class III devices
- Fast turnaround & revisions
Note: Package prices are tentative. Final charges depend on the actor role, the number of devices and the device classification.
Please message me before ordering so I can review your requirements and share an accurate quote.
Client must provide all required documentation.
Important Note: Competent Authorities Doesn't assure about timeline of registration confirmation So, Process can delay a little than the offered period. Charges mentioned on gig are flexible
Get to know Komal Razzaq
Komal Razzaq
Global Regulatory, and Compliance Consultant
Level 2
- FromPakistan
- Member sinceJun 2022
- Avg. response time1 hour
- Last delivery1 month
Languages
Urdu, Hindi, English, Chinese, Spanish, German
ISO, CE Marking, FDA, EUDAMED — if those acronyms give you a headache, you're in the right place.
I'm Komal, a QMS & regulatory compliance consultant with 7+ years helping medical device, food, and manufacturing companies get products into EU, UK, and US markets.
I handle ISO 9001/13485/14001/22000/27001/45001, CE Marking, EU MDR, FDA & MHRA registration, technical files, HACCP, and GMP.
Not sure exactly what you need? Send me a message with your product and target market. I'll tell you what's required, what's not, and how long it'll realistically take — no sales pitch.
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Who needs an SRN?
Manufacturers, EU Authorized Representatives, importers and system/procedure pack producers placing devices on the EU market.
Can non-EU manufacturers register?
Yes. Non-EU manufacturers need an EU Authorized Representative, who verifies the registration request. I coordinate this step.
How long does it take to get an SRN?
After submission, the Competent Authority validates the request. This usually takes from a few days to a few weeks, depending on the country.
Do I need a Basic UDI-DI before device registration?
Yes. It is assigned through an issuing entity such as GS1 or HIBCC. I can guide you if you don’t have one yet.
What do you need from me?
Company details, actor role, EU Authorized Representative details (for non-EU companies), device list, UDI data and certificates if applicable.
Do you also provide EU MDR documentation?
Yes. Check my separate EU MDR gig for technical documentation and Notified Body support.
