Cognetivity Neurosciences Secures Critical Quality Standard Certification

Cognetivity Neurosciences (CSE:CGN,OTCQB:CGNSF) has announced that its subsidiary, Cognetivity, has received ISO 13485:2016 certification for its Quality Management System after being reviewed by Lloyd Register’s Quality Assurance.

As quoted in the press release:

ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry, and its award demonstrates Cognetivity’s commitment to the highest level of medical device quality controls and to meeting customer and international regulatory expectations. The certification is a critical prerequisite to securing regulatory approval around the world, including European CE Marking and other regulatory certifications.

ISO 13485:2016 is the international standard for quality management systems for medical devices, under which an organization has shown via an in-depth auditing process that it is able to create medical devices and related services that meet applicable regulatory requirements. ISO is an independent, non-governmental, global organization that sets standards for compliance with industry best practices, and in May 2018 the US Food and Drug Administration (FDA) announced its intention to use ISO 13485:2016 as the new basis for its future quality system legislation.

“This ISO 13485 certification represents a key milestone on the path towards the full commercialization of our ICA tool. It illustrates our commitment to quality, our ability to reach the stringent criteria required for certification and further reinforces our dedication to ensuring our ICA platform is able to help as many people as possible in this critical area for healthcare.” said Cognetivity CEO, Dr. Sina Habibi.

Click here to read the full press release.