Internal Audit Services by EUmAccess GmbH
At EUmAccess GmbH, we offer comprehensive internal audit services to help medical device and in vitro diagnostic (IVD) manufacturers ensure compliance with ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA QSR (21 CFR Part 820). Our expert auditors provide independent, objective assessments to identify gaps, improve processes, and prepare for external audits.
Why Internal Audits Are Essential?
Ensure Compliance
Meet regulatory requirements (ISO 13485, MDR, IVDR, FDA, MDSAP)
Identify & Address Risks
Detect non-conformities before external audits
Improve Quality Processes
Strengthen your Quality Management System (QMS)
Prepare for Notified Body & Regulatory Audits
Reduce the risk of audit failures
Enhance Supplier & Manufacturing Compliance
Ensure supply chain reliability
Our Internal Audit Services
SO 13485:2016 & EN ISO 13485:2021 Internal Audits
- Assess QMS effectiveness & regulatory compliance
- Identify gaps & recommend corrective actions
- Prepare audit reports & follow-up plans
EU MDR 2017/745 & IVDR 2017/746 Compliance Audits
- Verify compliance with Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)
- Review Technical Documentation & Post-Market Surveillance (PMS)
- Conduct Mock Notified Body Audits
FDA 21 CFR Part 820 (QSR) Internal Audits
- Assess compliance with US FDA Quality System Regulations (QSR)
- Identify non-conformities before an FDA inspection
- Implement CAPA & risk management strategies
MDSAP (Medical Device Single Audit Program) Readiness Audits
- Ensure compliance with MDSAP requirements
- Audit across jurisdictions (USA, Canada, EU, Australia, Brazil, Japan)
- Identify gaps & recommend corrective actions
Supplier & Manufacturing Audits
- Evaluate supplier compliance with ISO 13485 & MDR/IVDR
- Conduct on-site & remote supplier audits
- Identify risks in the supply chain & manufacturing processes
GAP Analysis & Audit Readiness Assessments
- Pre-assessments before Notified Body, Competent Authority, or FDA inspections
- Identify & resolve non-conformities
- Support corrective & preventive actions (CAPA)
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.