4 December 2025 – We pleased to announce that EyRIS has successfully completed ISO 13485 recertification and the European MDR audit with zero non-compliance.
This achievement demonstrates continuous commitment to the highest quality and regulatory standards in the medical device industry.
Key highlights:
- Among the first companies in Singapore to secure HSA approval for an AI software as a medical device (SaMD).
- One of the first globally to upgrade compliance to the European MDR framework, setting a benchmark for innovation and responsibility.
- The recent audit included the presence of local accreditation and regulatory authorities, further validating dedication to transparency and excellence.
- Patient safety and effectiveness remain at the core of Eyris’ mission. This milestone reflects the hard work of the team and the focus on delivering safe, effective, and trusted medical technologies worldwide.
Our congratulations to the regulatory team for proving that innovation and compliance go hand in hand.
For media inquiries, please contact enquiry@eyris.io
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