Your technical documentation includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. CE Technical Documentation Requirements for medical device companies Emergo can assist medical device and IVD manufacturers transition to meet MDR and IVDR requirements for Technical Documentation. These requirements have changed from those under the European Union's previous Directives-the Medical Devices Directive (MDD) 93/42/EEC, the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. Compiling your technical documentation is a critical step in Europe's CE Marking process and a requirement for compliance with the Medical Devices Regulation (EU MDR 2017/745) and the In-Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746). How does MDR 2017/745 change EU Technical Documentation requirements?Ī CE Marking Technical Documentation (for high-risk Class III devices) is a comprehensive description of your device intended to demonstrate compliance with European regulatory requirements.What is the proper format for Technical Documentation?.Which device classes require Technical Documentation?.What is a European Technical Documentation?.
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started to make it integrated (only the idrac express, not the enterprise. But is it possible, in the express version, to select an already existing ethernet port for that purpose? So if the R720 comes with a 4-port NIC (like a Broadcom 5720), I could select one of the ports to be reserved for iDrac? Or. If youre able to view the OMSA, you can check the iDRAC license section there. I believe the enterprise version comes with a physical ethernet port. To have the enterprise version, I need specific iDrac hardware board and also a license to be applied on the interface? If I want to have a remote console, do I need to get the enterprise version? Or does the express version also provides this feature? 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