Press Release by VoxNeuro.
The 1.0 release of VoxNeuro’s SaaS platform, CHAMP, is days away. With this new federally-funded asset, VoxNeuro will graduate to the full-scale Software as a Service phase. This platform is a key component of our scaling plans, allowing us to service hundreds of assessment centers, with minimal human intervention.
VoxNeuro is continuing to progress towards ISO 13485:2016 / MDSAP certification having successfully advanced past the Phase I audit and with the Phase II certification audit slated for early this fall. Once certification is obtained, VoxNeuro is pursuing a Class II Medical Device License for CHAMP with Health Canada, which is expected in Q4 of this year.
On the U.S. front, VoxNeuro has been working closely with the FDA towards the submission of a 510(k) application for CHAMP. Barring unforeseen delays, we are targeting Q1 2021 for our FDA clearance.
“VoxNeuro is committed to providing products and services that fully meet the requirements and expectations of our customers, and are in compliance with all applicable regulatory requirements in the regions that we serve. Through this commitment we at VoxNeuro hope to not only provide our products and services globally, but continuously improve upon the quality of those products and services.” Adam Masciangelo, Regulatory Affairs Associate.