XTalks
MAY 13, 2022
Depending on the type of product or study scope, there are three main approaches for E&L evaluations (the approach selected depends on the purpose or application, and the FDA branch the submission falls under): Pharmaceutical Containers Closure Systems: involves compliance with USP <661.2>, > umbrella).
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022.
XTalks
JUNE 12, 2023
Siemens Healthineers further demonstrated its commitment to innovation at the European Congress of Radiology in Vienna, showcasing its revamped Acuson ultrasound portfolio. Significantly, Roche received full compliance under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) from the European Union.
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