We’re excited to share that Xpedite Diagnostics is now ISO 13485 certified! Our products are CE IVD-R registered and this certification marks a significant achievement, reflecting our commitment to adhering to the highest international standards in medical device quality management.
ISO 13485 certification is widely recognized in the healthcare industry, ensuring our products consistently meet safety, reliability, and regulatory standards. We also offer certification services to OEM customers, enabling them to leverage our regulatory expertise to ensure compliance and quality in their own offerings.
As we continue to innovate for point-of-care diagnostics, this accomplishment reinforces our dedication to providing trusted solutions in in-vitro diagnostics. We thank the whole team at Xpedite and our certification partner Quality Austria for making this possible!