von 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...
von 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...
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 | 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...
von 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...
