von Martina Riebenbauer | Feb 6, 2020 | Functional Safety, Medical Devices, Safety, Training
The development of medical devices is driven by risk identification and mitigation. Let´s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as IEC 60601 and its particular standard 60601-2-4 is a...
von Martina Riebenbauer | Jan 30, 2020 | Automotive, Functional Safety, Qualitymanagement
We are entering the fifth year after the IATF 16949:2016 standard has been published. The due date for the transition audit from old standard version ISO/TS 16949:2009 to the new version IATF 16949:2016 was mid of September 2018. So by now the affected organizations...
von Martina Riebenbauer | Jan 28, 2020 | Automotive, Event, Functional Safety, Medical Devices, Qualitymanagement, Uncategorized
We are happy to announce that this February will be our 3rd time at the embedded world in Nuremburg. Embedded world is the leading international trade fair for embedded system technologies and takes place from 25 to 27 February 2020. It promises to be one of...
von Martina Riebenbauer | Dez 13, 2019 | Automotive, Functional Safety, Qualitymanagement
Welcome to the third and final part of the blog series ‘Integration of IATF 16949 & ISO 26262’. In this final part of the blog I will continue to examine, in this case the similarities regarding change & document management in the two standards. QM...
von Martina Riebenbauer | Nov 27, 2019 | Functional Safety, Medical Devices, Safety, Training
Complying with regulatory requirements is a daily activity for software developers in the medical device industry. With the requirements of IEC 62304 on the life cycle for the development of the medical software and software within medical devices certain demands are...
