Tag: ISO
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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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Sharpening the Standards That Underpin Medical Laboratory Quality: Singapore at the Vancouver ISO/TC 212/WG 1 Meeting
Singapore’s engagement with international standards for medical laboratory quality and competence took another step forward in spring 2026, as Dr Adrian Yeo, Convenor of the National Mirror Working Group on ISO/TC 212, travelled to Vancouver, Canada, to participate in the 43rd meeting of ISO/TC 212/WG 1 on Quality and competence…
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On the Path to ISO: Singapore’s Whole Genome Sequencing Quality Proposal Advances at Sendai Plenary
Singapore’s growing engagement in international genomics data standards took a meaningful step forward in May 2026, as representatives from CoRE-SDO and the National Mirror Working Group on ISO/TC 215/SC 1 Genomics Informatics travelled to Sendai, Japan, to participate in the 13th ISO/TC 215/SC 1 Plenary Meeting and the 12th meeting…
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Global Experts Unite in Berlin to Advance Standardisation for Next-Gen Cancer Diagnostics
On 24-25 June 2025, a major milestone in biomedical innovation was achieved as global experts gathered for the inaugural Project Team Meeting of ISO/AWI 25725 — launching a pioneering initiative to standardise the design and workflow requirements for in vitro diagnostics (IVDs) in next-generation sequencing (NGS)-based oncology applications. Held in…