Otohub announced that it has earned ISO 13485:2016 and EN ISO 13485:2016 certification from the British Standards Institution (BSI) for its Quality Management System for the following scope: Design and development of mobile software applications for audiology.
“We are so excited about this ISO certification, which is critical for us to develop the best audiology technology in the market in accordance to the highest quality standards worldwide,” said Dr Antonio Curci, co-founder and executive director of Otohub Srl. “Our team worked so hard to achieve this further milestone: Otohub and its products are now FDA Registered, ISO13485 Certified, and HIPAA Compliant and CE Mark pending. I am so proud to be part of this wonderful company!”
ISO13485 is said to be recognized internationally as a universal measure of quality and is a prerequisite to securing CE Mark and other regulatory certifications. Specifically, the ISO 13485 certification reportedly indicates that product samples are regularly subjected to rigorous, independent testing to ensure that they comply with stringent standards for safety, product performance, or reliability, as evidence of a firm commitment to the safety and quality of medical devices.
“The software technology used to develop our unique audiology products allows us to easily accommodate any market needs, including language options,” said Dr Gianna Lardaro, co-founder and executive director R&D of Otohub Srl. “And, of course, our innovative and unique Tone Generation Engine of all our products is already calibrated to the accepted international ANSI Standards (ANSI S3.6) and ISO-EN Standards (EN60645).”