von Martina Riebenbauer | Sep 26, 2019 | Event, Functional Safety, Medical Devices, News, Qualitymanagement, 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...
von Alastair Walker | Aug 13, 2019 | Uncategorized
Google analytics is a wonderful thing. Since we published our series of blogs on ISO 26262 Safety Element out of Context (SEooC) at the end of 2017, this series has been a clear leader in our rankings, hence this has brought us to a fourth blog on SEooC and since the...
von Linda Stein | Jun 26, 2018 | Uncategorized
In our previous blog on the Medical Device Regulation (MDR) we focussed on how the MDR will support safer product development. In this blog we look at the alignment of the MDR with best industry practice and the current maze of medical device standards. The MDR Annex...
von Linda Stein | Jul 27, 2017 | Uncategorized
In the final part of our ISO 26262 part 11 blog, we look at the additional information added to support semiconductor manufacturers assess dependent failures in integrated circuits. The DFA section of part 11 provides guidelines for the identification and analysis of...
von Linda Stein | Mrz 2, 2017 | Uncategorized
For safety relevant or safety critical medical devices (where section 14 of IEC 60601-1 Programmable Medical Electrical Systems (PEMS) is applicable), system architects and development teams are faced with a daunting list of items to consider in their PEMS...
