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MedEnvoy Global

Your Global Partner for Medical Device Regulatory Compliance.

2020 - Presente (5+ anos)
Registro

Sede: Austin, Texas, USA

Sobre MedEnvoy Global

We are a specialized provider of regulatory compliance and in-country representation services for the medical device and in-vitro diagnostic (IVD) industries. The company serves as a European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, and US Agent. We are distinguished by offering independent importer services, allowing manufacturers to maintain control over their supply chain while meeting Article 13 obligations under the EU MDR and IVDR.

Por que Escolher MedEnvoy Global?

Single provider for EU, UK, and Swiss representation and importer services

Independent importer model preserves manufacturer control over distributors

ISO 13485:2016 certified quality management system

Team of senior regulatory experts with decades of industry experience

Seamless compliance solutions for EU MDR and IVDR requirements

Global reach including US and Australian market support

Especializações

7+ Serviços

Presença Global

5 Escritórios

Idiomas

4 Idiomas

Mercados

9 Regiões

Atualizações Recentes

EU Launches Evidence on Targeted Revision of MDR and IVDR

September 11, 2025

Regulatory Update
New List of Low-Risk and Deregulated Medical Devices in Mexico

July 7, 2025

Global Regulatory
ISO 15223-1 Amendment 1:2025 Updates for Medical Devices

April 8, 2025

Standards Update