by Martina Riebenbauer | Nov 26, 2020 | Automotive, Quality Management, Uncategorized
The IATF 16949 standard defines the different processes of a quality management system in a company. It refers to various other standards in order to be able to implement the individual processes. In this blog series, I will explain which standards are necessary to...
by Martina Riebenbauer | Nov 12, 2020 | Automotive, Medical Devices, Quality Management
In 1989, on November 9th, the first World Quality Day was organized by the Chartered Quality Institute in London. Since then, the World Quality Day is celebrated annually on the second Thursday in November. But what can you do in a company on a World Quality Day? The...
by Martina Riebenbauer | Nov 10, 2020 | Automotive, Functional Safety, Medical Devices, Reliability, Safety
In my second part of the blog series, I want to point out the importance of soft error rates and their consideration in applications in different industries. Furthermore, I will touch upon the evaluation methods of soft error rates, and the possible mitigation and...
by Martina Riebenbauer | Oct 20, 2020 | Reliability, Safety
Soft errors are well known in the informatics as special form of errors, which could cause an unexpected and unintentional state of a logic circuit or data memory. Other than errors caused by defects in the hardware which permanently change the system, only temporary...
by Martina Riebenbauer | Sep 22, 2020 | Medical Devices, Safety
One of the key topics over the last few years in the medical device sector is the introduction of Software as a Medical Device SaMD. The activities initially driven by the International Medical Device Regulators Forum (IMDRF) then finding its way into standards such...
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...
