Page last updated: Nov 25, 2024

TIIM Healthcare Regulatory

Our products undergo evaluation based on the most stringent regulatory benchmarks, ensuring the highest standards of quality and compliance and safety.

ISO 13485

Logo of ISO13485 endorsement from BSI

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.

View certificate

CLS(MD) Level 1

CLS(MD) Level 1 Label

Demonstrating compliance with baseline cybersecurity requirements

aiTriage v1 has met CLS(MD) Level 1 requirements. This recognizes the system’s robust design to ensure it's resilience against evolving threats.

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HSA certified

aiTriage v1 has been cleared by the Health Sciences Authority (HSA) of Singapore as a Class C medical device.

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View HSA certificate

MDA certified

aiTriage v1 has been cleared by the Medical Device Authority (MDA) of Malaysia as a Class C medical device.

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View MDA certificate

VMOH certified

aiTriage v1 has been cleared by the Ministry of Health of Vietnam as a Class B medical device.

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View VMOH certificate

Manufacturer address

TIIM Healthcare Pte. Ltd.
203 Henderson Road
Henderson Industrial Park, #12-13
Singapore 159546

Incident reporting

Please contact us if you have discovered a potential issue with the aiTriage v1 product. Note that any information submitted will be governed by our privacy policy.
Email: support@tiimhealthcare.com(opens in a new tab)

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