Regulatory clearances and certificates
aiTriage™ v1 is cleared as a Class C medical device by Singapore's Health Sciences Authority and Malaysia's Medical Device Authority, and as a Class B medical device by Vietnam's Ministry of Health. It is built under a quality management system certified to ISO 13485:2016 by BSI. Every certificate is published below with its issuing authority.
CLS(MD) Level 1
Demonstrating compliance with baseline cybersecurity requirements
aiTriage v1 has met the CLS(MD) Level 1 requirements of Singapore's Cyber Security Agency, which assess a medical device's baseline cybersecurity design.
Class C cleared
aiTriage v1 has been cleared by the Health Sciences Authority (HSA) of Singapore as a Class C medical device.
ISO 13485
Technology recognised for its high standards
Our Quality Management System (ISO 13485:2016) is certified for the design and development, manufacture and distribution of risk stratification software for triage. As well as the import, storage, distribution, installation and servicing of patient monitoring and electrocardiograph devices.
- Issued October 4, 2024
Class C cleared
aiTriage v1 has been cleared by the Medical Device Authority (MDA) of Malaysia as a Class C medical device.
Class B cleared
aiTriage v1 has been cleared by the Ministry of Health of Vietnam as a Class B medical device.
Manufacturer address
TIIM Healthcare Pte. Ltd.
203 Henderson Road
Henderson Industrial Park, #12-07
Singapore 159546
Reporting an incident
If you suspect that aiTriage v1 has been involved in a serious incident, or you have found a potential safety issue, report it to us at the address below. As the manufacturer, we report to the competent authority in each market where the device is cleared. Users may also report directly to their national authority. Information submitted is governed by our privacy policy.
Email: support@tiimhealthcare.com