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

EU Market Access – Auth. Rep. and Consulting services

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

CE Mark
e-IFU Software solution

MDR / EUDAMED

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