Health Canada have issued updated guidance for medical device recalls - Overview: Guide for recalling medical devices (GUI-0054) - Canada.ca
Ben KempDecember 18, 2024
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 KempNovember 6, 2024
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 KempNovember 6, 2024