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I will register your medical devices in eudamed
Medical Device Regulatory and QMS Consultant
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 man...
Level 2
Has met high performance criteria and has a proven track record for meeting client expectations.
About this Gig
Are you a medical device manufacturer, importer, distributor, or EU Authorized Representative needing EUDAMED registration support?
I provide professional assistance with EUDAMED Actor Registration, SRN registration, UDI/Device registration, and related medical device regulatory activities under EU MDR 2017/745 and IVDR 2017/746.
My services include:
- EUDAMED Actor Registration and SRN support
- Manufacturer, Importer, Distributor and Authorized Representative registration
- UDI/Device registration and data preparation
- Basic EUDAMED regulatory assessment
- Device information and EMDN-related data review
- EUDAMED data preparation and submission support
- Review of existing EUDAMED registrations
- Identification and correction of registration/data gaps
- Regulatory documentation and checklist support
- Guidance for EU MDR/IVDR EUDAMED requirements
Whether you are registering as a Manufacturer, Importer or Authorised Representative, I can provide structured assistance based on your specific situation.
Please contact me before ordering so I can review your company, role, device(s), and required EUDAMED service and recommend the appropriate package.
Language:
English
•
Urdu
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
My Portfolio
FAQ
1. What is EUDAMED?
EUDAMED is the European Database on Medical Devices established under EU MDR 2017/745 and IVDR 2017/746. I provide assistance with applicable EUDAMED registration and data submission activities.
2. Can you register my company in EUDAMED?
Yes. I can assist with EUDAMED Actor Registration, including preparation and submission support for manufacturers, importers, distributors and EU Authorized Representatives.
3. Can you help obtain an SRN?
Yes. I can prepare and support the Actor Registration process required to obtain an SRN. Final validation and issuance are performed by the relevant competent authority.
4. Can you register medical devices in EUDAMED?
Yes. I can assist with UDI/Device registration and preparation of the required device information.
5. Can you register multiple devices?
Yes. I can support multiple-device registrations. Please contact me first so I can provide a customized offer based on the number and type of devices.
6. Do you provide EU Authorized Representative services?
No. This Gig focuses on EUDAMED registration and related regulatory support. EU Authorized Representative services can be discussed separately where applicable.
7. Can you register multiple devices?
Yes. Multiple-device registration can be handled depending on the number and complexity of devices. Please contact me first for a customized quote.
