von Martina Riebenbauer | Mai 20, 2020 | Functional Safety, Medical Devices
Your updated ‘cheat sheet’ to hazard analysis terminology in medical devices. (May 2020) We’ve already seen how a key part of ensuring functional safety is a robust risk management system. The first step in risk management is assessing risk; a key initial part of that...
von Martina Riebenbauer | Apr 29, 2020 | Functional Safety, Medical Devices
In this blog we look at the guidance for medical device manufacturers in relation to post-market surveillance and more specifically how cybersecurity concerns impact these activities. For all of us active in the medical device sector the topic of post-market...
von 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...
von 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...
von Alastair Walker | Apr 9, 2020 | Functional Safety, Medical Devices
In the first part of this blog series Blog Part 1 on the forthcoming version of IEC/DIS 62304 we focused on the move to support Software as a Medical Device (SaMD) in the standard. In this part we look at the biggest enhancement in the new version, the class reduction...
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 –...
