Queensland-based Laronix ISO 13485 Certified

Image credit: Laronix

Queensland-based medtech, Laronix has hit another big milestone, having officially been confirmed as an ISO 13485:2016 certified medical device manufacturer for the design, development and the manufacturing of its ground-breaking artificial larynx devices.

“This certificate following the multi-stage audit of notified body British Standards Institution confirms that all our activities, from design and development to manufacturing, are fully compliant with the demanding regulations of medical device development and ISO 13485:2016,” said Laronix in a statement.

“It also confirms the fact that Laronix is well capable to provide safe and well established artificial larynx devices for our laryngectomy users.”

A winner of the Bionics Challenge in 2021, Laronix’s wearable device provides a natural-sounding voice to people with voice loss through a combination of sensors and processing via artificial intelligence.

Not only offering a male or female voice option, this revolutionary technology also gives users back the ability to laugh and even sing – bringing with it great hope to the potentially millions of people globally set to benefit from the device.