Clarix Imaging ISO 13485, EN ISO 13485, and MDSAP Certification Announcement

Clarix Imaging has successfully obtained ISO 13485, EN ISO 13485 and MDSAP certifications.

We are delighted to announce that Clarix Imaging has recently successfully obtained the ISO 13485, EN ISO 13485, and MDSAP (Medical Device Single Audit Program) certifications for both the US and Canada.

The ISO 13485 Quality Standard is internationally recognized and underscores a device manufacturer's commitment to excellence in quality management and safety.  MDSAP is recognized by the International Medical Device Regulators Forum whose member countries include Australia, Brazil, Canada, Japan, and the US.  These certifications affirm that Clarix imaging’s VSI-360™ real-time 3D micro-CT technology for intraoperative specimen imaging meets these stringent standards.

“We are incredibly proud of this achievement. This truly reflects the dedication of Clarix Imaging to its Quality Policy and commitment to empowering our customers with innovative, highly reliable, and quality products.  These new certifications will significantly bolster our efforts to expand our global presence.” said Xiao Han, CEO and Co-Founder.

The award of these certifications marks a significant milestone bringing Clarix Imaging closer to our goals. It’s an accomplishment worth celebrating.