AEvice Health Receives ISO 13485:2016 Certification
Singapore, November 19, 2020 – AEvice Health, a MedTech company developing wearables for chronic respiratory disease patients, announced today that it has been awarded ISO 13485:2016 certification for Medical Device and Quality Management Systems (QMS) from TÜV SÜD. This ISO certification indicates that AEvice Health has met stringent regulatory requirements specific to the medical device industry.
“Obtaining ISO13485 certification is a significant milestone for the company. This certification reflects our commitment to quality in every product we build, meeting international regulatory standards. It is also an important stepping stone in AEvice Health’s expansion strategy into the EU market, ” said AEvice Health’s Commercial Lead, Edmund Shao.
ISO 13485:2016 is an internationally recognized quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
About AEvice Health
AEvice Health Pte Ltd is a Singapore-based MedTech spin-off from Nanyang Technological University at the forefront of addressing chronic respiratory disease, one of the generation’s biggest healthcare challenges.
The company’s non-invasive wearable devices enable the early detection of cardiopulmonary abnormalities remotely and in real-time so that patients can receive fast and targeted care from the ease of their homes. Clinicians can also gain insights into their patients’ health and track their responses to treatment plans easily from the AEvice analytical platform.
In AEvice Health, our mission is to drive medical innovations that transform healthcare, improve outcomes and empower lives.
More information about the company can be found at www.aevice.com.
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