Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

Successful PAT implementation should start small, with the goal of integrating data into decision-making and fostering cross-functional collaboration.

Highlights full year 2025 Revenue of EUR 4.1bn in 2025, representing year-on-year growth of 1.3% in constant currency (-2.4% on a reported basis).

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...