Human factors in medical devices has evolved from a regulatory requirement into a core patient-safety discipline. Integrating usability engineering across the device lifecycle, particularly in real-world conditions, reduces use-related risk and strengthens post-market learning.

Sterile services are essential to patient safety, yet UK training still focuses on procedures over purpose, relies on outdated methods. Global evidence shows that modern, learner-centred approaches, such as mobile and modular training, reduce errors and improve staff performance. Without…

Haptic feedback is a critical missing component in surgical robotics, limiting precision, increasing cognitive load, and constraining training and AI development. Integrating touch into robotic systems could significantly improve clinical outcomes, enable better skill transfer, and unlock new capabilities in…

Apple and WHOOP are taking two starkly different paths toward blood pressure monitoring. Their divergence underscores how design, intent, and evidence define whether wearables are wellness tools or medical devices.

The European Commission has proposed new regulatory pathways under EU MDR for orphan and breakthrough medical devices, aiming to speed access for rare disease treatments and highly innovative technologies. These routes would allow expert panel designation, prioritised notified body review,…

Medical device manufacturers often fall short of CE and ISO 13485 requirements because quality isn’t treated as a continuous discipline. Common failures include superficial risk management, outdated technical files, unvalidated processes, weak supplier oversight, shallow CAPA investigations, poor document control,…

Legacy medical devices previously CE marked under MDD/AIMDD must now meet MDR’s stricter clinical evidence requirements, including enhanced equivalence standards, continuous PMS/PMCF activities and comprehensive data documentation.