Skip to content

+41766405728 Asti (IT) / Zug (CH) / Shanghai (CN) / Stevenage (UK) info@advanxa.eu

EU Market Access – Auth. Rep. and Consulting services

EU Auth. Rep. service
CE Mark
MDR / EUDAMED
- MDR Support request
- UDI/EUDAMED SUPPORT
Swiss Aut Rep
UKCA
- UK Responsible Person support
Smart Certificate Validator
Reach out
Search for:

Authorized Representative Priority Assessment

We can perform a priority assessment of your product documentation to speed up the process.

In 1 working day you will be contacted by our experts to initiate the process.

Fill in the below information in order to start the process!

Prefix

First Name *

Last Name *

Email Address *

Company Name *

Website

Phone Number

Street Address

City

State/Province

ZIP / Postal Code

Country

Type of Regulation

EU MDR - Class IEU MDR - Class IIaEU MDR - Class IIbEU MDR - Class IIIMachineryElectrical EquipmentPPE

Type of products

Load Declaration of conformity

Drag and Drop (or) Choose Files

Notified body (if available)

Available documentation

Device DescriptionTechnical FileManual/IFULabellingRisk FileClinical Evaluation (only Medical Device)Manufacturing ProcessPMS (only Medical Device)Test Reports

Load up files

Drag and Drop (or) Choose Files

Additional notes0 / 180

Our Services

EU Auth. Rep. service
CE Mark
MDR / EUDAMED
- MDR Support request
- UDI/EUDAMED SUPPORT
Swiss Aut Rep
UKCA
- UK Responsible Person support
Smart Certificate Validator
Reach out

International Medical Device Registration Guidances

USA Regulatory Framework Medical Device registration
Taiwan Regulatory Framework Medical Device registration
South Korea Regulatory Framework Medical Device registration
South Africa Regulatory Framework Medical Device registration
Singapore Regulatory Framework Medical Device registration
Saudi Arabia Regulatory Framework Medical Device registration
Russia Regulatory Framework Medical Device registration
Peru Regulatory Framework Medical Device registration
Malaysia Regulatory Framework Medical Device registration
Japan Regulatory Framework Medical Device registration
Canada Regulatory Framework Medical Device registration
China Regulatory Framework Medical Device registration
Costa Rica Regulatory Framework Medical Device registration
Egypt Regulatory Framework Medical Device registration
Hong Kong Regulatory Framework Medical Device registration
India Regulatory Framework Medical Device registration
Reach out

Auth. Rep. Support

CE Mark
e-IFU Software solution

MDR / EUDAMED

Reach out