Regulations
FDA: Software Assurance guidance for Production and Quali…
This draft guidance is intended to:
Computer Software Assurance is a risk-based approach to establish confidence…
Mexico: Modifications to Medical Device Registration
In August 2023, the Mexican regulatory authority for medical devices, COFEPRIS, released an updated guidance documen…
Swissmedic Device/IVD Database Key Dates
Swissmedic now handles registration of economic operators, medical devices and In-vitro diagnostic medical devices d…
What EU MDR changes mean to Manufacturers & what’s N…
With EU MDR timelines extended, some brief analysis for manufacturers:
Devices benefitting
The extension provi…
Two Keys for Successful Regulatory Digital Journey
Despite years of discussion, understanding what digital journey or transformation means for most companies remains a…
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