MEDICALAU

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MEDICALAU GROUP

Wholly Owned by MEDICALAU | One-stop Global Cross-border Compliance Provider

Exclusive Compliance Partner for Manufacturers & Cross-border Sellers

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10 +

Years of Experience

100 +

Kinds Device

3000 +

Customers

3000 +

Project Completed

ABOUT US

Wholly owned subsidiary of MEDICALAU, our company fully aligns with high-standard compliance requirements at home and abroad.

About
  • One-stop EU & US Compliance Service

  • Services Cover 50+ Countries & Regions, Full-range EU & US Compliance in One Stop

  • Compliance Escort, Brands Sold Worldwide

  • One-stop Testing & Certification for All Product Categories

All about us
01

EU Authorized Representative

02

FDA Registration (USA)

03

UK Responsible

04

GSI Registration

05

UDI Coding & Implementation

06

D-U-N-S Number Registration

07

FDA Registration (Eyewear)

08

CE Certificate (Poland Issued)

09

CE Certificate (Italy Issued)

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Global Service Network, Offer Compliance Support Anytime Anywhere

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Cross-border Product Compliance & Certification Services

Specialized in cross-border e-commerce compliance testing & certification; global product safety certification services available worldwide.

Product Inspection

Provide full-process quality control inspection, conducting comprehensive checks on raw materials and finished products to ensure they meet specifications and mitigate risks from the source.

Product Testing

Follow authoritative domestic and international standards, tailor customized testing plans, and deliver precise, detailed test reports along with improvement recommendations.

Audit & Certification

Leverage a professional team and scientific systems to offer comprehensive factory and supplier audit services, reducing supply chain risks.

Product Compliance

Conduct in-depth research on global regulations and policies, accurately identify key requirements, help enterprises navigate risks, and ensure products compliantly enter target markets.

Client Feedback

What Our Clients Say

MEDICALAU GROUP helped us prepare for a major regulatory audit with just two weeks' notice. Their team identified gaps we didn't even know existed and got us inspection-ready in days.

James Anderson

Business Owner

We were struggling with post-market surveillance reporting until MEDICALAU GROUP stepped in. They streamlined our entire process and gave us full confidence going forward.

Sarah Mitchell

Business Owner

MEDICALAU GROUP's strategic guidance on global market access saved us from several costly missteps. Their insights go far beyond just checking boxes.

Thomas Bennett

Business Owner

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