This post is to remind members that the nominations process for the RAPS Board of Directors is open. RAPS is seeking qualified individuals to serve as directors for the 2021-2023 term. This is an opportunity to help lead RAPS to serve regulatory professionals and shape our regulatory profession. The Board is the strategic governing and policy body ...

From FDA website  https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns excerpts " American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns:  tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission...  ...

Hello, Under the MDR and IVDR the requirement for Technical Documentation encompasses many technical information associated with the product including parts of the Design History File (DHF).  You are really looking at parts of the DHF that would be provided as part of the Technical Documentation review by a Notified Body.  The Technical Documentation ...

14971:2019 added a definition for reasonably foreseeable misuse, "use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior". This needs to consider all types of users and can be intentional or unintentional. I think there are several things at play in the question. Here is a ...

Today's case count is 763, an increase of 20% over yesterday's count, so the rate is still declining. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ------------------------------