https://orcid.org/0000-0001-5120-5776
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Usman Iqbal, Peter Lachman, Phillip Phan, From compliance to excellence: how can ISO 13485 standards transform quality, safety, and innovation in medical devices?, International Journal for Quality in Health Care, Volume 37, Issue 2, 2025, mzaf032, https://doi.org/10.1093/intqhc/mzaf032
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Background
The medical device industry operates in a high-stakes environment where quality and safety are paramount. The recent published paper in the Journal by Pacheco et al. (2025) explores strategies to improve International Organization for Standardization (ISO) standard 13 485:2016 implementation in the medical device industry [1]. ISO 13 485, the gold standard for medical device Quality Management Systems (QMS), provides a structured approach to regulatory compliance and risk management. Pacheco et al. emphasize that advancing ISO 13 485 maturity requires a structured framework to evaluate compliance, leadership commitment, and resource allocation for digital tools and operational excellence—key drivers for minimizing risks and ensuring patient safety. However, successful implementation of the standard remains an ongoing challenge due to the complexities of integration, operational excellence, and the evolving regulatory landscape [1, 2]. The authors argue that fostering a culture of continuous improvement, aligned with ISO 13 485’s lifecycle requirements from design to post-market surveillance, is critical for addressing inherent industry complexities and maintaining regulatory adherence. For example, integration with hospital information systems for tracking device traceability and managing recall protocols demands significant investment in digital infrastructure. In one documented instance, a hospital struggled with integrating supplier data and tracking device performance due to siloed data systems, delaying compliance [3]. Smaller medical device companies, in particular, face resource constraints that complicate efforts to align supply chain management systems with ISO 13 485. Pacheco et al. emphasize that maturity models, tailored to ISO 13 485 requirements and incorporating Plan-Do-Study-Act cycles, can guide organizations from ad hoc practices to optimized processes, bridging gaps in empirical evidence, and providing actionable benchmarks [1].
