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Presentation Download | Impact of the EU AI Act on Medical Device and IVD Manufacturers

AI Artificial Intelligence

October 03, 2023

"Toetsingskader Post-Market Surveillance | IGJ | September 2023 | Version 1.7"

September 08, 2023

Free Webinar PDF Download | Medical Device Registration in Asia-Pacific Part II

Australia Global Registration India Malaysia Medical Device Regulations New Zealand Regulatory Affairs Regulatory strategy Webinar

Free Webinar Q&A Document | Medical Device Registration Asia-Pacific part I

China Market Access China Medical Device Regulations Regulatory Affairs Singapore Webinar

Diane Ward, IVD development expert, contributed to design the studies used in the article of the Journal of Microbiological Methods

Performance evaluation of InfectID-BSI: A rapid quantative PCR assey for detecting sepsis-associated organisms directly from whole blood

Clinical Affairs Clinical Data Clinical Performance Studies CLSI In-Vitro Diagnostics IVDR Regulatory Affairs

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