12 Jan 2023

Neurosoft Bioelectronics Receives ISO 13485 Certification for Quality Management System

Startup brings implantable brain-computer interfaces one step closer to clinical studies and regulatory approval

Neurosoft Bioelectronics is proud to announce that it has received ISO 13485:2016 certification by TÜV SÜD for its Quality Management System. This is a major milestone as it brings the company one step closer to clinical studies and regulatory approval for its innovative soft implantable electrode and BCI systems.

A big congratulations to the entire team for their commitment to quality and hard work. With this certification, Neurosoft Bioelectronics is one step closer to its goal of providing monitoring and diagnostics for drug-resistant epilepsy patients as well as patients suffering from brain tumors, and to advance future therapies in development, starting from the treatment of Severe Tinnitus through closed-loop cortical neuro-stimulation.

Read the full press release here.

Welcome to Prasannah Atputharasa - our new Quality Affairs intern

Neurosoft Bioelectronics adds experts in Neuromodulation & Tinnitus to its Advisory Board