Tag: Medical Devices
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TR 151:2026 Launches – Singapore Sets a Common Bar for Medical Device Clinical Investigations
From a wearable patch that tracks heart rhythm to software that reads retinal scans for signs of disease, a growing number of medical devices are now being designed and tested in Singapore. Before any of them reaches a patient, it must go through a clinical investigation, and the strength of…
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Evidence Under Review: A Day of Regulatory Practicums in Singapore
Good clinical evidence does not announce itself. It has to be built, claim by claim, endpoint by endpoint, and then read the same way by everyone who looks at it. That was the focus of Day 03 of Duke NUS Medical School’s GMS5008 module, Regulation and Clinical Evaluation of Medical…
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One Standard, Many Hands: Singapore Helps Sharpen ISO Guidance on Medical Device Quality Management in Prague
A single medical device rarely stays in one pair of hands. It may be designed in one country, manufactured under contract in another, sterilised by a third party, and finally distributed to hospitals through a fourth. Holding that entire chain to a consistent standard of quality is the quiet, unglamorous…
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Advancing Quality and Cyber Resilience in Singapore’s Medical Device Landscape
On 10 September 2025, the Biomedical Engineering Society (BES), the Duke-NUS Centre of Regulatory Excellence – Standards Development Organisation (CoRE-SDO), and the co11ab Novena jointly organised the workshop ‘Ensuring Quality and Cyber Resilience’. The event gathered stakeholders from healthcare institutions, regulatory agencies, industry, and academia to explore how quality management…