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...
by Martina Riebenbauer | Nov 5, 2019 | Automotive, Functional Safety, Quality Management
Welcome to the second part of the blog series “Integration of IATF 16949 & ISO 26262”. In the last blog entry I tried to take away fears when dealing with ISO 26262 for the first time. Many requirements and topics of the two standards overlap and...
by Martina Riebenbauer | Oct 22, 2019 | Functional Safety, Medical Devices
In the first part of our blog on the future of IEC 60601-1 we looked at the topics in the forthcoming amendment 2. In this second part of our blog we concentrate on some of the topics that might be added to a wish list for a future revision of IEC 60601-1. ...
by Alastair Walker | Oct 17, 2019 | Functional Safety, Medical Devices
When a revised standard or guidance document is released there is always a heightened level of anticipation to see what’s been added/updated/removed. The second amendment of IEC 60601-1, due for release in October 2020, is no different. The first amendment came out in...
by Martina Riebenbauer | Oct 10, 2019 | Automotive, Functional Safety, Quality Management
When one of my former employers talked about functional safety for the first time on one of the new projects, I saw two types of expression. The first facial expression of many colleagues was: I do not know that, I never heard of it. The second look expressed a kind...
by Martina Riebenbauer | Sep 26, 2019 | Events, Functional Safety, Medical Devices, News, Quality Management, Uncategorized
Last week the 26th EuroSPI Conference took place in Edinburgh which welcomed all international participants with unexpected beautiful weather. The three-day event offered exceptional key notes, interesting industry news and 10 different workshops focusing above all on...
by Martina Riebenbauer | Sep 17, 2019 | Quality Management
Welcome back to another blog related to quality management topics. In this instalment we will take a look at one of the key concepts of ISO 9001:2015 – the role of top management in communication as part of the implementation and maintenance of and effective and...
by Martina Riebenbauer | Sep 10, 2019 | Events, Medical Devices, Quality Management
Good question! We didn´t know either until the day Stuart Hardie spoke about quality management at this year´s Product Design Scotland´s annual summer design event at the breath-taking Saint Luke´s church in Glasgow. The event was all about exploring the role of...
