Helius Medical Technologies, Inc. has announced that its wholly owned subsidiary, NeuroHabilitation Corp., has been assessed by Lloyd’s Register Quality Assurance Limited (LRQA) and recommended for ISO 13485 certification for its Portable Neuromodulation Stimulator (PoNS), an investigational noninvasive device designed to deliver neurostimulation through the tongue.
LRQA, an independent certifying agency, concluded that the company complies with the requirements of ISO 13485 for an integrated quality management system for medical devices across all functions of the business, from design and development to manufacturing and distribution.
Achievement of ISO 13485 certification constitutes an important regulatory milestone in the commercialization process for the company’s products. The ISO 13485 standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.
“The ISO 13485 certification illustrates our commitment to quality, our ability to reach milestones required for product commercialization and, above all, our dedication to seeing PoNS Therapy through to approval,” said Helius CFO/COO, Joyce LaViscount.
With this certification, Helius will be proceeding with a CE Mark application in Europe, a Health Canada Medical Device License Application for Canada and a Therapeutic Goods Association application for Australia.
Helius Medical Technologies Inc.