Regulations
FDA: Software Assurance guidance for Production and Quality System Software
This draft guidance is intended to:
Comput…
Mexico: Modifications to Medical Device Registration
In August 2023, the COFEPRIS, the Mexican Regu…
What EU MDR changes mean to Manufacturers & what’s Next !
With EU MDR timelines extended, some brief ana…
Two Keys for Successful Regulatory Digital Journey
Despite years of discussion, understanding wha…
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