Ensure Compliance, Quality & Reliability with EUmAccess GmbH
At EUmAccess GmbH, we provide independent third-party inspection services to help medical device (MD) and in vitro diagnostic (IVD) manufacturers ensure product quality, safety, and regulatory compliance. Our expert inspectors conduct thorough evaluations at various stages of production, from raw material inspection to final product release, ensuring adherence to ISO 13485, MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, and MDSAP standards.
Why Choose Third-Party Inspections?
Unbiased Quality Assessment
Independent verification of product compliance
Regulatory Compliance
Ensure adherence to ISO 13485, MDR, IVDR, FDA, and MDSAP
Reduce Defects & Rework
Identify issues early to prevent costly recalls
Supplier Quality Contro
Ensure raw materials & components meet specifications
Improve Customer Confidence
Guarantee high-quality, regulatory-compliant products
Our Third-Party Inspection Services
Incoming Material & Component Inspection
- Verify raw materials, components, and subassemblies before production
- Ensure compliance with technical specifications & regulatory requirements
- Identify non-conforming materials before they affect production
In-Process Inspection & Monitoring
- Conduct real-time production line inspections to detect defects early
- Verify adherence to manufacturing procedures & quality standards
- Ensure compliance with Good Manufacturing Practices (GMP)
Pre-Shipment & Final Product Inspection
- Perform final product verification before shipment
- Ensure product labeling, packaging, and documentation meet regulatory requirements
- Prevent defective products from reaching the market
Packaging & Labeling Compliance Inspection
- Confirm that labeling meets MDR, IVDR, FDA, and other market-specific regulations
- Verify that packaging protects the product & maintains sterility (if applicable)
- Prevent mislabeling, a key cause of regulatory non-compliance
Supplier & Manufacturing Facility Inspections
- Assess supplier quality management systems (QMS)
- Conduct audits to verify ISO 13485 & regulatory compliance
- Ensure risk-based supplier management strategies
Risk-Based Inspections & Process Validation
- Conduct risk assessments in compliance with ISO 14971:2019
- Validate critical manufacturing processes to maintain consistent product quality
- Ensure that non-conformities are detected & addressed proactively
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.