Supplier Audit Services by EUmAccess GmbH
At EUmAccess GmbH, we provide comprehensive supplier audit services to help medical device and in vitro diagnostic (IVD) manufacturers ensure their suppliers meet ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA QSR (21 CFR Part 820) requirements. Our expert auditors assess supplier compliance, mitigate risks, and enhance supply chain reliability.
Why Supplier Audits Are Essential?
Regulatory Compliance
Ensure suppliers meet ISO 13485, MDR, IVDR, and FDA requirements
Quality Assurance
Verify suppliers maintain consistent product quality & process control
Risk Mitigation
Identify & resolve potential supply chain risks
Supplier Qualification & Monitoring
Evaluate new suppliers & ensure ongoing compliance
Improve Supply Chain Efficiency
Strengthen relationships with reliable, compliant partners
Our Supplier Audit Services
ISO 13485:2016 & EN ISO 13485:2021 Supplier Audits
- Assess supplier compliance with QMS requirements
- Review documentation, processes, & risk management practices
- Identify non-conformities & recommend corrective actions
MDR 2017/745 & IVDR 2017/746 Supplier Audits
- Ensure suppliers meet EU MDR/IVDR requirements
- Assess materials, manufacturing, & post-market compliance
- Conduct Technical Documentation & Quality Agreement reviews
FDA 21 CFR Part 820 (QSR) Supplier Audits
- Verify compliance with US FDA Quality System Regulations (QSR)
- Ensure Good Manufacturing Practices (GMP) are followed
- Identify gaps & help suppliers meet FDA expectations
MDSAP (Medical Device Single Audit Program) Supplier Audits
- Assess supplier compliance with MDSAP across multiple jurisdictions
- Cover regulations in USA, Canada, EU, Australia, Brazil, & Japan
- Conduct risk-based supplier evaluations & CAPA implementation
On-Site & Remote Supplier Audits
- Perform on-site visits to manufacturing & supply facilities
- Conduct remote audits for document & process verification
- Provide detailed audit reports & compliance recommendations
Supplier Qualification & Performance Monitoring
- Audit new suppliers for approval & onboarding
- Conduct periodic assessments for ongoing compliance
- Implement Corrective & Preventive Actions (CAPA) for non-compliant suppliers
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.