Published July 2026 | Practical guidance for medical-device founders, QA/RA leaders, software teams, and AI governance owners. ISO 42001 vs ISO 13485 is not a choice between two competing quality standards. ISO 13485:2016 is the regulated medical-device quality management system backbone. ISO/IEC 42001:2023 is an organization-wide artificial intelligence management system standard that adds governance for … Read more
The EU MedTech Innovation Pressure: Navigating 2026 “Crunch” and EY-DG SANTE Findings For years, the European Union was the global launchpad for EU MedTech Innovation, but recent data suggests a pivotal identity crisis is looming. A “CE Mark” was often the first major milestone for a startup before tackling the FDA. However, the tide has … Read more
MEDICAL ROBOTICS: Enhancing Surgical Procedures and Patient Outcomes The advent of medical robotics has revolutionized the way surgical procedures are performed, offering unprecedented precision and control. This transformative technology has not only enhanced the capabilities of surgeons but also significantly improved patient outcomes. The technology continues to revolutionize the way surgeries are performed, leading to … Read more
