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 Submitted

Our solution has been submitted for FDA approval as a de novo technology for heart rate and respiratory rate measurement.

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.