by Alastair Walker | Nov 20, 2015 | Medical Devices, Primers
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...
by 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...
by Martina Riebenbauer | Jun 10, 2020 | Automotive, Functional Safety
In this blog we revisit the subject of dependent failures as defined in ISO 26262 (Part 11: Blog Post 3: Dependent Failure Analysis 2017) and more to the point how they can be quantified. Depending on the item under development the number of potential dependent...
by Martina Riebenbauer | Jun 5, 2020 | Automotive, Functional Safety, Reliability, Safety
In the second part of my blog series (Part 1 was about reliability prediction analysis) I want to focus on different failures and calculation models that can be used for your reliability prediction, as well as about the different standards and handbooks for...
by Martina Riebenbauer | May 13, 2020 | Automotive, Functional Safety, Quality Management
In the first part of my new blog series I want to focus on one of the key elements when talking about reliability: prediction. Reliability prediction for electronic components or systems is a very important part of the development or design phase and provides help to...
by 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...
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 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...
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...
