The Front End of Innovation (FEI) is the most uncertain yet critical stage of product development. Decisions made here - from identifying opportunities to selecting ideas - determine up to 80% of innovation outcomes. By focusing on customer insights, balancing…

Clinical evaluation is a continuous, strategic process that underpins both regulatory approval and commercial success for medical devices. Early alignment on intended purpose, clinical strategy, and evidence generation is critical. Tools such as the Target Product Profile and State of…

AI is driving major advances across Smart Health - from sensor-rich wearables to imaging diagnostics and adaptive SaMD. These innovations promise earlier detection and personalised care, but also highlight the need for robust validation, transparent algorithms, and real-world evidence. Progress…

EU MDR 2017/745 significantly elevates the role of medical device registries as sources of real-world clinical evidence across the product lifecycle. While registries offer powerful advantages for post-market surveillance and continuous compliance, their regulatory value depends on data quality, governance,…

The EU Commission has proposed targeted amendments to the MDR and IVDR (COM(2025)1023) to reduce regulatory burden, streamline Notified Body assessments, and support innovation while maintaining patient safety. Key measures include defined conformity assessment timelines, risk-based audits, greater use of…

Advanced neurotechnologies demand manufacturing discipline as rigorous as the science behind them. By embedding cleanroom process control, risk management, and structured validation early, Class III device manufacturers can achieve reproducibility, regulatory compliance, and long-term reliability. The result is scalable innovation…

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.