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 standards and cybersecurity practices can work together to support the next generation of connected medical technologies.
The seminar opened with an introduction to Singapore’s standards ecosystem by Ms Yang Fan, Head of CoRE-SDO, who highlighted the national standardisation programme overseen by Enterprise Singapore. Within this ecosystem, CoRE-SDO—established in 2023—supports the Biomedical and Health Standards Committee (BHSC) under the Singapore Standards Council (SSC) in developing and promoting biomedical and health standards. These initiatives are central to aligning regulatory expectations, accelerating innovation, and fostering the adoption of standards that advance both industry growth and public health.
Quality Across the Medical Device Lifecycle
The workshop then underscored the importance of quality management systems as the backbone of medical device safety and performance. Discussions focused on how robust processes guided by global frameworks such as SS ISO 13485 and the U.S. FDA Quality Management System Regulation (21 CFR Part 820) help maintain traceability and meet regulatory requirements across every stage of a device’s journey, from development to post-market oversight.
A key message was that quality is not merely a compliance requirement but a continuous approach that evolves alongside emerging technologies and clinical needs. Embedding quality considerations from the outset helps organisations build safer products and enhance patient outcomes.
Cybersecurity as a Core Safety Imperative
As digital technologies become more deeply integrated into healthcare, cybersecurity is increasingly recognised as a fundamental component of patient safety. Connected medical devices that are capable of transmitting data and supporting remote care will introduce new vulnerabilities that require proactive risk management.
Technical Reference 67 (TR 67) offers a comprehensive framework for integrating cybersecurity into each phase of a device’s lifecycle, covering design, risk assessment, implementation, and long-term maintenance. With its alignment to both regulatory expectations and practical considerations, TR 67 enables stakeholders across the healthcare ecosystem to build safer connected technologies.
A Collaborative Path Forward
The workshop underscored that quality and cybersecurity must advance hand in hand as dual pillars of patient safety. Strong cross-sector partnerships will be essential to building a healthcare ecosystem in Singapore that is both secure and sustainable.
By integrating quality and cybersecurity, the biomedical community is shaping a safer environment for connected medical technologies—one where innovation can progress with trust and patient safety at its core.
