© nexeon Electronics Production | April 20, 2017
Nexeon Medsystem receives ISO 13485 certification
Belgium-based Nexeon Medsystems complies with the European requirements of ISO 13485 and EN ISO 13485. A comprehensive quality management system for the design and manufacture of implantable neurostimulation system is in place.
The company management has described this as a critical milestone on the path to launching its neuromodulation platform, both for its indication in deep brain stimulation ("DBS") for Parkinson's disease as well as follow-on products for other neurological diseases. "Nexeon has an ongoing commitment to delivering the most advanced and highest quality neuromodulation devices for the treatment of neurologic diseases," said Nexeon VP of Quality Dr. Stéphane Béfahy. He continued, "We are deliberately investing in our design and production processes in preparation for the commercial launch of our first product as well as the delivery of products for third-party device contracts that are currently in progress." Since 2013, the team at Nexeon Belgium has received both research grants and commercial contracts to advance the development and manufacture of its neuromodulation platform and related peripherals. The grants include a EUR 3.4 million funded consortium partnership in alignment with Minister Marcourt's e-health initiative for the Walloon Region in Belgium. The company's most notable commercial contract is a multi-year agreement with Galvani Bioelectronics, a joint venture of Google/Verily and GlaxoSmithKline (GSK). The contract is ongoing as Galvani exercised its option to enter the second phase last year. "This is an important step in our goal to becoming a significant player in the future of bioelectronics medicine," said President and Chief Commercial Officer Brian Blischak, who has spent the last 15 years leading all aspects of global commercialization for five different neuromodulation product lines. In addition to his time spent in the neuromodulation division at St. Jude Medical, Blischak's product development experience includes implantable neurostimulation systems for obsctructive sleep apnea, three DBS product lines, and an implantable infusion pump. "We're building a neuromodulation platform with unique capabilities in stimulation and sensing that can be leveraged to spawn multiple neuromodulation solutions for multiple indications."