by Martina Riebenbauer | Sep 1, 2020 | Automotive, Functional Safety, Medical Devices, Safety
In the first part of this blog (Software Safety Analysis Part 1) we looked at requirements management and traceability as key activities in the reliable implementation of software projects. In this part of the blog we look at the importance of a qualitative overview...
by Kirstin McKellar | Aug 19, 2020 | Automotive, Functional Safety, Medical Devices, Safety
A hot topic for many years has been the definition of the best safety (risk) analysis technique for analysing potential software malfunctions. Like many discussions of this nature there is no clear answer and the decision is often application and complexity dependent....
by Kirstin McKellar | Aug 5, 2020 | Automotive, Functional Safety, Medical Devices, Safety
The challenges of safety-related continuous delivery In our previous blog we looked at the way the medical device sector is evolving. Specifically, we explored why this can lend itself to support the activities of continuous integration (CI) and continuous delivery...
by 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...
by Martina Riebenbauer | Jul 9, 2020 | Automotive, Functional Safety, Reliability
Welcome to the third and final part of the reliability blog series. I ‘ve already written about reliability prediction analysis and focused on different failures and calculation models. In this last part of the blog, I will continue to discuss the different...
by Martina Riebenbauer | Jun 19, 2020 | Automotive, Medical Devices
A term we encounter regularly in safety related industries is state of the art. Top level documents in different industries e.g. ISO 26262 in automotive or the Medical Device Regulation (MDR) often sprinkle the term throughout with the expectation that organisations...
by Martina Riebenbauer | Jun 10, 2020 | Automotive, Functional Safety
In this blog we revisit the subject of dependent failures as defined in ISO 26262 (Part 11: Blog Post 3: Dependent Failure Analysis 2017) and more to the point how they can be quantified. Depending on the item under development the number of potential dependent...
by 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...
by Martina Riebenbauer | May 13, 2020 | Automotive, Functional Safety, Quality Management
In the first part of my new blog series I want to focus on one of the key elements when talking about reliability: prediction. Reliability prediction for electronic components or systems is a very important part of the development or design phase and provides help to...
by Martina Riebenbauer | Apr 29, 2020 | Functional Safety, Medical Devices
In this blog we look at the guidance for medical device manufacturers in relation to post-market surveillance and more specifically how cybersecurity concerns impact these activities. For all of us active in the medical device sector the topic of post-market...
