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Sharan Murugan
Nov 3, 20242 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
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Sharan Murugan
Oct 2, 20242 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA)Â has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
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Sharan Murugan
Mar 16, 20231 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
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