Following an intensive audit process, we can confirm our certification by NQA as an ISO 13485 accredited Company.

ISO 13485 is the international standard for Quality Management Systems: Medical Devices. The standard is wide reaching, covering everything from design and development of software to product validation, post market surveillance and in depth document/management requirements. This certification is welcome recognition of our team’s hard work to entrench the standard in everyday life here at Neuronostics and reflects our commitment to high standards and patient safety.

We wanted to build a QMS that wouldn’t just pass certification now, but scale with us as we grow as a business. This meant customising software, reviewing all our processes from scratch and bringing together the team’s expertise in the different areas involved.

Our Head of Regulatory Affairs, Lucy Rogers, said:

“We are really excited about the doors this opens for us as a Company and the strong position it puts us in to deliver on our upcoming regulatory milestones. But most importantly, we are delighted to show our clinicians that we have built a quality, effective and safe product to aid in diagnosing epilepsy.”