von Martina Riebenbauer | Mrz 31, 2020 | Medical Devices
Over the last year we have posted a series of blogs on the changing landscape of the medical device safety standards, the updated ISO 14971 and Amd 2 of 60601. Today we turn our attention to the forthcoming edition 2 of IEC 62304. IEC/DIS 62304 Health software –...
von Martina Riebenbauer | Mrz 19, 2020 | Automotive, Functional Safety, Medical Devices, Safety
One topic that has cropped up time and time again in ISO 26262 is the discussion on hardware parts and can/should requirements be assigned to them? Section 7.4.1.5 in ISO 26262-5:2018 gives the statement ‘The traceability between hardware safety requirements and...
von Martina Riebenbauer | Mrz 4, 2020 | Automotive, Event, Functional Safety, Medical Devices, Qualitymanagement
Last week Alastair Walker and Dijaz Maric attended the Embedded World Conference in Nuremberg (Germany) – the leading international trade fair for embedded system technologies. Despite difficult general conditions, we decided to take part at the fair and it was...
von Martina Riebenbauer | Feb 6, 2020 | Functional Safety, Medical Devices, Safety, Training
The development of medical devices is driven by risk identification and mitigation. Let´s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as IEC 60601 and its particular standard 60601-2-4 is a...
von Martina Riebenbauer | Jan 30, 2020 | Automotive, Functional Safety, Qualitymanagement
We are entering the fifth year after the IATF 16949:2016 standard has been published. The due date for the transition audit from old standard version ISO/TS 16949:2009 to the new version IATF 16949:2016 was mid of September 2018. So by now the affected organizations...
