Quality Assurance & Regulatory Affairs

We are committed to delivering true solution excellence.
Our devices are designed with quality and usability as top priority and are evaluated to the highest standards.

FDA

Donisi’s revolutionary contact-free multiparameter measurement system received clearance by the U.S. Food and Drug Administration for detection of heart rate and respiratory rate via the FDA’s De Novo pathway.

FDA Pre-submission

We are in discussions with the FDA for contact-free detection of atrial fibrillation (AFib) via a pre-submission process.

ISO 13485 Certified

We maintain an ISO 13485 certified Quality Management System.