- Home
- About
- Representative Service
- MS & CE Marking Consultancy
- ISO 13485:2016 & EN ISO 13485:2016 + A11:2021
- Medical Device Single Audit Program (MDSAP)
- MDR | Regulation (EU) 2017/745)
- IVDR | Regulation (EU) 2017/746
- Technical Files (EU) MDR745/ IVDR746
- Risk Assessment for Medical Devices – ISO 14971:2019
- CER, PMS, PMCF, PSUR, SSCP
- Validation QMS Software and SaMDs
- Expert Services
- Trainings
- Career
- Contact
EU Authorised Representative
(E.A.R) Services
Your Trusted Partner for Regulatory Compliance
SERVICES
Our Strength
We offer QMS and Technical Reviewers, Supply Chain Inspectors, Quality System Auditors and Experts, Product Conformity Assessors, Regulatory and Certification Experts, and Qualified Trainers in Global Framework.
Representative Service
As your EU Authorised Representative (E.A.R), manage EUDAMED, COC for Class I devices, product registrations, market approvals, & Free Sales Certificates (FSCs).
MS & CE Marking Consultancy
We ensure compliance with ISO 13485, MDSAP, MDR, IVDR, including Technical Files, Risk Assessment, CER, PMS, PMCF, PSUR, SSCP, and QMS/SaMD validation.
Expert Services
QA outsourcing, audits, third-party inspections, UDI support, code research, TF review, and Notified Body application services.
Trainings
Expert training on regulatory compliance, QMS, and industry best practices to keep your team competitive and enhance overall operational efficiency.
Why Choose EUmAccess GmbH as Your E.A.R?
Regulatory Expertise
Our team of experienced professionals possesses in-depth knowledge of EU regulations, ensuring accurate and up-to-date guidance.
Client-Centric Approach
We tailor our services to meet the specific needs of each client, providing personalized solutions for seamless regulatory compliance.
Comprehensive Support
From initial consultation to full regulatory compliance, we support you at every stage of the process.
Commitment to Excellence:
Our goal is to empower businesses with the knowledge and tools needed to succeed in the European market.
VISION
To be the leading regulatory consultancy firm, empowering medical device and IVD manufacturers with innovative, efficient, and reliable compliance solutions that ensure patient safety and market success.
QUALITY POLICY
At EUmAccess GmbH, we are committed to delivering high-quality regulatory and compliance services that meet the stringent requirements of ISO 13485 and ensure the highest standards of safety, efficacy, and reliability for medical devices and in vitro diagnostic (IVD) products.
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
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.