von Martina Riebenbauer | Jul 24, 2020 | Automotive, Functional Safety, Medical Devices, Safety
One of the biggest challenges as a functional safety consultancy, is marrying up modern software methods and techniques with safety related requirements, and at the same time trying not to be over restrictive with the methods and processes and the advantages these can...
von Martina Riebenbauer | Jun 5, 2020 | Automotive, Functional Safety, Reliability, Safety
In the second part of my blog series (Part 1 was about reliability prediction analysis) I want to focus on different failures and calculation models that can be used for your reliability prediction, as well as about the different standards and handbooks for...
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...
