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EUmAccess GmbH – Your Trusted Partner for Regulatory Compliance

At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.

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Our Expertise

EU Authorized Representative Services

Acting as your official EU Representative, ensuring compliance with MDR (2017/745) and IVDR (2017/746) requirements.

Management System Consultancy

Assisting in the implementation and maintenance of ISO 13485, ISO 9001, and other relevant management systems for quality assurance and regulatory compliance.

CE Marking Consultancy for Medical Devices and IVDs

Guiding manufacturers through the CE marking process, technical documentation, conformity assessments, and regulatory approvals.

Training Services

Providing expert training programs on regulatory compliance, quality management systems, and industry best practices to ensure your team stays ahead in the competitive market.

Customized Regulatory Solutions

Offering tailored consultancy services to address unique business challenges and specific compliance needs, ensuring seamless operations in the European market.