by Martina Riebenbauer | Apr 21, 2020 | Functional Safety, Medical Devices
In this fourth and final part of our IEC/DIS 62304 blog series (Part 1: Its a class app, Part 2: Its a different class, Part 3: How agile are you?) we look at the relationship between the forthcoming version of 62304 and the challenges of cybersecurity. Over...
by Martina Riebenbauer | Apr 16, 2020 | Functional Safety, Medical Devices
In this third part of our four-part series (Part 1: Its a class app and Part 2: Its a different class) on the up and coming IEC/DIS 62304 we look at the relationship between the standard and the world of agile software development. The forthcoming version of the...
by Martina Riebenbauer | Mar 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 –...
by Martina Riebenbauer | Mar 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...
by Martina Riebenbauer | Mar 4, 2020 | Automotive, Events, Functional Safety, Medical Devices, Quality Management, Training
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...
