What are the documentation requirements for in-house IVDs?

Dec 3, 2010 ... A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, ... 2 days ago ... Is your IVD medical device ready for the EU IVDR deadline? The IVDR enhances in vitro diagnostic medical device safety and performance, ... Nov 13, 2024 ... In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical ... IVD devices are tests used on biological samples (such as tissues, blood, or urine) to determine the status of a person's health. D2a. Investigational In Vitro Medical Device Dossier (IMDD-IVD. The Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) specifies the content ... May 16, 2012 ... Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device'. Study Group 1 Final Document GHTF/SG1/N071:2012. May ... The documents below detail the requirements that UNICEF applies to medical devices, in vitro diagnostics devices and personal protective equipment (PPE). Sep 8, 2021 ... MedTech Europe Survey Report – Analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in May 2022 when the new EU IVD Regulation applies. Register and certificate your Medical Devices and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device ...