Yofo Strengthens Global Quality and Compliance with MDR, ISO 13485 and MDSAP Certifications

26 January 2026 | Company

Yofo Medical has reached another milestone in its global development with three key certifications: EU MDR, ISO 13485 and MDSAP.

Together, these certifications demonstrate Yofo’s continued commitment to internationally recognized quality management, regulatory compliance and product safety, providing a stronger foundation for serving customers across global markets.

Three Certifications. One Global Quality System.

Each certification addresses a different part of medical device quality and compliance, together forming a comprehensive framework for Yofo’s international operations.

MDSAP:
Supporting Access to the US and Brazil

The Medical Device Single Audit Program (MDSAP) enables one regulatory audit to address quality management requirements recognized by participating regulatory authorities.

Yofo’s MDSAP certification supports its regulatory development in the US and Brazil, helping streamline quality system oversight across these important markets.

YOFO MDSAP certificate — MDSAP Certificate

EU MDR:
Meeting Europe’s Regulatory Requirements

The EU Medical Device Regulation places rigorous requirements on medical device safety, performance, clinical evidence and post-market oversight.

Yofo’s MDR certification demonstrates conformity with applicable European regulatory requirements within the certified scope and provides an important foundation for expanding its presence in the European market.

YOFO EU MDR certificate — MDR Certificate

ISO 13485:

Quality Built into Every Process

ISO 13485 is the internationally recognized quality management standard for medical devices.

Certification confirms that Yofo has established systematic quality controls across key processes, from product development and manufacturing to regulatory management and ongoing quality assurance.

YOFO EN ISO 13485 certificate — ENISO 13485 Certificate

It also provides an important foundation for Yofo’s broader MDR and MDSAP compliance.

Building Trust Through Quality

For medical imaging technology, global expansion begins with more than product performance. It requires consistent quality, validated processes and compliance throughout the product lifecycle.

These certifications represent another step in Yofo’s long-term commitment to building precision imaging solutions that meet the expectations of healthcare professionals and partners worldwide.

As Yofo continues to expand internationally, we will keep strengthening our quality and regulatory systems to deliver safe, reliable and clinically valuable imaging solutions at scale.