von Martina Riebenbauer | Mrz 19, 2020 | Automotive, Functional Safety, Medical Devices, Safety
One topic that has cropped up time and time again in ISO 26262 is the discussion on hardware parts and can/should requirements be assigned to them? Section 7.4.1.5 in ISO 26262-5:2018 gives the statement ‘The traceability between hardware safety requirements and...
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 | 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...
von Martina Riebenbauer | Nov 12, 2019 | Automotive, Event, News, Safety
Last week the Austrian Lorit Consultancy Team, Alastair Walker, Dijaz Maric and Martina Riebenbauer spent a whole day at the automotiv.2019 conference in Linz, Austria. This year it was all about getting connected, autonomous driving and what the future brings, which...
von Martina Riebenbauer | Mai 20, 2019 | Automotive, Safety
Like for most suppliers in the automotive industry, car manufacturers (OEMs) require from electronics suppliers to deliver their products according to the IATF 16949 Automotive Quality Management System Standard. With the new edition of the Automotive Standard, IATF...
von Martina Riebenbauer | Mai 13, 2019 | Automotive, Safety
In our final part of this three-part blog on the recently published Publicly Available Specification ISO/PAS 21448:2019 ‘Road vehicles – Safety of the intended functionality’ (SOTIF) we focus on the topic of how SOTIF approaches human factors and compare this...
