Month: September 2019

EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents

EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 Manufacturer incident report Helptext 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020

EU – Some documents related to Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices

Application form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Procedural guidance on declaration of interests – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Declarations on confidentiality and commitment – Call […]

US FDA Final and update guidances – Software

Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance details the changes to existing guidance documents that relate to the regulation of the software functions. As such, the FDA updated the following final […]