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Regulatory Partners Release guidelines for PCCPs

January 29, 2024

The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...

WHO Urges Nations to Adopt National Strategies for Diagnostics

June 16, 2023

In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association...