Nuheara Achieves international medical device quality certification
- Nuheara (NUH) has achieved international medical device quality certification in addition to the certification for its non-regulated devices
- The company received 13485:2016 certification which means Nu heara has successfully met all the requirements, mainly whether it is effective while safe to use
- The company says this certification is an “important next milestone” after receiving FDA approval for its HP Hearing PRO over the counter (OTC) self-fit hearing aid
- Managing Director Justin Miller says the certification is another key step in rolling out company’s medical device growth strategy in the US
- Shares in the company are down 2 per cent to trade at 24.5 cents at 1:53 pm AEDT
