SOTA Cloud Achieves ISO 13485:2016 Certification, Reinforcing Commitment to Quality and Patient Safety

Dental imaging software provider demonstrates dedication to quality and compliance.

Orange, CA – May 2026 – SOTA Cloud, the leader in cloud-based dental imaging solutions, has successfully achieved ISO 13485:2016 certification for its Quality Management System through an MDSAP audit. The certification, issued by Intertek – an MDSAP recognized Auditing Organization — covers the design, manufacture, and distribution of Picture Archiving Computer Systems (PACS).

SOTA Cloud’s QMS certification helps ensure its PACS software is safe, reliable, and consistently meets stringent regulatory requirements at every stage, from design through distribution. Achieving this certification demonstrates SOTA Cloud’s commitment to high standards of quality and patient safety, giving dental practices and patients even greater confidence in its products.

“Achieving MDSAP certification to ISO 13485:2016 is a proud milestone for our entire team,” said Dustin Johnson, CTO and Co-Founder of SOTA Cloud. “It reflects the dedication that goes into everything we build and gives our customers the assurance that our software is held to the highest standards. With MDSAP, SOTA Cloud is a step closer to reaching regulated markets globally.”

ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, is an international standard that specifies QMS requirements for organizations involved in the design, manufacture, installation, and servicing of medical devices and related services. Certification demonstrates SOTA Cloud’s ability to consistently meet customer expectations and applicable regulatory requirements across its device lifecycle.

The Medical Device Single Audit Program (MDSAP) enables a single, comprehensive audit of a medical device manufacturer’s QMS — conducted by an Auditing Organization (AO) recognized by participating regulatory authorities — to simultaneously satisfy the audit requirements of multiple jurisdictions. SOTA Cloud’s MDSAP certification covers the regulatory requirements of the United States (FDA) and Canada (Health Canada).