PathologyAI is now certified to ISO 13485:2016, the international quality management system standard for medical device manufacturers. The audit was conducted by a notified body over the course of the first quarter and covered our full product development, clinical validation, and post-market surveillance processes.
What the certification means
ISO 13485 is the gold-standard framework for how a medical device is designed, built, validated, and maintained throughout its lifecycle. Certification confirms that every step of our process — from the data we use to train models, to how changes are reviewed and released, to how real-world performance is monitored after deployment — meets the same rigor that large diagnostic companies operate under.
For the hospitals and laboratories that rely on our software, it means predictability. Any update they receive has passed formal risk analysis, clinical review, and traceable change control before it reaches their workflow.
The road to CE IVDR
ISO 13485 is a prerequisite for CE marking under the In Vitro Diagnostic Regulation (IVDR). With the certificate in place, our regulatory team is now finalizing the technical documentation for our first two IVDR submissions: HER2 quantification in breast cancer and high-risk flagging for gastrointestinal biopsies.
We expect to complete both submissions before the end of the year and to move into clinical use at partner sites shortly thereafter.
