The forthcoming move from ISO 9001:2015 to ISO 9001:2026 builds on the existing ISO 9001 framework, refining how the standard is understood and applied. What will ISO 9001:2026 mean for medical device manufacturers?  For medical device manufacturers operating an ISO 9001:2015 Quality Management System, the transition to ISO 9001:2026 will… Read more

As the transition to the UK Medical Device Regulations 2002 continues, Post-Market Surveillance (PMS) has become a core requirement for maintaining device conformity. The current regulatory environment expects manufacturers to demonstrate ongoing performance and safety using real-world data, with PMS operating as a living part of the quality system rather… Read more