Yeng & Leong is pleased to announce that we are working with Vivo Diagnostics Pte Ltd to implement the ISO 13485 quality management system. We are also involved in developing the product regulatory strategy as well as providing regulatory support throughout the design stages for the company’s new HFMD rapid test kit. This includes development of usability studies, performance evaluation, risk management, manufacturing transfer and regulatory submission. The end goal is to have Vivo Diagnostics’ HFMD rapid test kit ready and approved for use as an in vitro diagnostic (IVD) device in their target markets.
Vivo Diagnostics Pte Ltd is a Singapore-based start-up in the biomedical diagnostics space. By partnering class-leading research institutes and technology players, the company aims to identify and commercialise novel disruptive diagnostic technologies to address diseases with a primarily Asian demographic.
At Yeng & Leong, we believe that a robust quality system and regulatory support is key to success for all medical technology companies. We are committed to supporting start-ups and incubators in these aspects.