by Alastair Walker | Apr 9, 2020 | Functional Safety, Medical Devices
In the first part of this blog series Blog part 1 on the forthcoming version of IEC/DIS 62304 we focused on the move to support Software as a Medical Device (SaMD) in the standard. In this part we look at the biggest enhancement in the new version, the class reduction...
by Martina Riebenbauer | Mar 31, 2020 | Medical Devices
Over the last year we have posted a series of blogs on the changing landscape of the medical device safety standards, the updated ISO 14971 and Amd 2 of 60601. Today we turn our attention to the forthcoming edition 2 of IEC 62304. IEC/DIS 62304 Health software –...
by Martina Riebenbauer | Mar 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...
by Martina Riebenbauer | Mar 4, 2020 | Automotive, Events, Functional Safety, Medical Devices, Quality Management, Training
Last week Alastair Walker and Dijaz Maric attended the Embedded World Conference in Nuremberg (Germany) – the leading international trade fair for embedded system technologies. Despite difficult general conditions, we decided to take part at the fair and it was...
by Martina Riebenbauer | Feb 6, 2020 | Functional Safety, Medical Devices, 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...
by Martina Riebenbauer | Jan 30, 2020 | Automotive, Functional Safety, Quality Management
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...
by Martina Riebenbauer | Jan 28, 2020 | Automotive, Events, Functional Safety, Medical Devices, Quality Management
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...
by Martina Riebenbauer | Dec 13, 2019 | Automotive, Functional Safety, Quality Management
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...
by 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...
by Martina Riebenbauer | Nov 12, 2019 | Automotive, Events, 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...
