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AMDEA Monthly Newsletter

Please see the newsletter from AMDEA and note the comments regarding the Product Regulation and Metrology Bill (IVD’s maybe in scope, and many off the shelf accessories used with IVDs will definitely be in scope). Lithium batteries is one such device that will be in scope, but which is not specifically identified in the present legislation framework. Note also the…
Ben Kemp
November 6, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI October Newslettter

Members may be interested in updates on: the transfer of CLSI EP37 Supplemental Information on Exogenous substances to an online database, the upcoming webinars, the Introduction of CLSI AUTO11 - Information Technology Security of In Vitro Diagnostic Instruments and Software Systems, 3rd Edition. You can find the newsletter here.
Ben Kemp
November 6, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

2024 Global Outlook for chemicals & chemical products: Mid-year review for the Americas

During this one-hour webinar, expert analysts will share insights on recently amended regulatory developments across the Americas in 2024 so far, plus look at what’s coming up. Join on Wednesday 4 September by clicking here. 
Ben Kemp
August 27, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMembership NewsMembership News Archive

IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
admin
June 25, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Cystic Fibrosis Trust Industry Symposium

The Cystic Fibrosis Trust are hosting an industry symposium "Accelerating CF Research: Strategies for rapidly progressing your science to clinical impact" on the 05 June 2024 in Glasgow. This event aims to showcase the support available for researchers to tap into and ways to accelerate their research projects. More information on this event and registration can be found here.
admin
May 22, 2024
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