Outsource Quality Assurance (QA) with EUmAccess GmbH
At EUmAccess GmbH, we provide comprehensive outsourced Quality Assurance (QA) solutions for medical device and in vitro diagnostic (IVD) manufacturers. Our expert QA outsourcing services ensure regulatory compliance, risk management, and continuous quality improvement, helping businesses meet the requirements of ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA regulations.
Why Outsource Your Quality Assurance?
Reduce Operational Costs
No need for an in-house QA team
Stay Compliant
Ensure compliance with ISO 13485, MDR, IVDR & FDA QSR
Access Industry Experts
Work with qualified QA professionals
Focus on Core Business
Let us handle QA management, audits & compliance
Scalable Solutions
Tailored to your business needs
Our Quality Assurance Outsourcing Services
Quality Management System (QMS) Implementation & Maintenance
- ISO 13485:2016 & EN ISO 13485:2021 certification support
- Development & maintenance of QMS documentation
- Internal audits & gap analysis
- Supplier & third-party audits
Regulatory Compliance & Audits
- Compliance with EU MDR 2017/745 & IVDR 2017/746
- MDSAP & FDA 21 CFR Part 820 audit preparation
- Notified Body & Competent Authority audit support
- Corrective & Preventive Actions (CAPA) management
Document Control & Process Management
- Standard Operating Procedures (SOPs) creation & updates
- Technical File & Design Dossier maintenance
- Risk Management (ISO 14971:2019) compliance
- Post-Market Surveillance (PMS) & Vigilance support
Supplier Quality Management
- Supplier audits & qualification
- Supplier risk assessments & monitoring
- Corrective actions for non-compliant suppliers
Training & Continuous Improvement
- ISO 13485 & MDR/IVDR regulatory training
- Internal auditor training
- CAPA & root cause analysis training
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.