Aural Analytics achieves “gold standard” ISO certifications directly following FDA registration, deepening its commitment to the highest quality clinical-grade speech analytics on the market
PHOENIX–(BUSINESS WIRE)–#Aid—Aural Analytics, Inc., a leader in clinical-grade speech analytics, today announced it was awarded certification to ISO 9001: 2015, a general quality management system certification that covers the non-medical device usage of its speech analytics product, and ISO 13485: 2016, a quality management standard that includes specific requirements for medical devices. The certifications demonstrate the company’s dedication to upholding global standards for quality assurance and quality management. Both certifications were issued by TÜV SÜD America Inc.
“Our Speech Vitals technology is being used in 30 concurrent clinical studies. As our technology continues to scale and expand in number of lives impacted, ensuring the highest quality standards are in place is of the greatest importance,” said Judy Smythe, CEO of Aural Analytics. “We have taken the necessary steps to meet or exceed all criteria, which includes these important ISO certifications.”
TÜV SÜD America Inc., a subsidiary of TÜV SÜD AG (Munich, Germany), is a leading globally recognized testing and certification organization. TÜV SÜD’s Business Assurance division provides management system certification services to ISO 9001, ISO 14001, AS9100, Safe Quality Food (SQF), and more. TÜV SÜD America also provides a comprehensive suite of services for the medical device sector as a European Union notified body for the medical device, active implantable medical device and in-vitro diagnostic device directives, and a complete service portfolio including ISO 13485 and MDSAP certification, FDA 510(k) and third-party inspections.
Aural Analytics is developing its Speech Vitals technology to address unmet needs in the marketplace for early detection of Alzheimer’s disease, disease progression tracking and medication titration for Parkinson’s disease, screening for mental health issues such as depression, among many other uses. The company recently received US Food and Drug Administration (FDA) registration for its clinical-grade speech analytics product, Speech Vitals, as a computerized cognitive assessment aid, a class II software medical device (SaMD). Aural Analytics built a quality management system (QMS) to meet FDA and other regulatory requirements.
To learn more about Aural Analytics and its Speech Vitals product, visit www.auralanalytics.com.
About Aural Analytics, Inc.
Aural Analytics is the industry’s leading speech neuroscience company harnessing the clinical utility of the world’s speech across the age range and around the world. Their suite of applications and embeddable SDKs and APIs are available in more than 25 languages across Android, iOS, and the web and are easy to use, secure, and provide robust, clinically relevant, interpretable, and validated metrics reflecting the neurological and respiratory health of its users. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter, LinkedIn, Medium, and Facebook.