von Kirstin McKellar | Aug 5, 2020 | Automotive, Functional Safety, Medical Devices
The challenges of safety-related continuous delivery In our previous blog we looked at the way the medical device sector is evolving. Specifically, we explored why this can lend itself to support the activities of continuous integration (CI) and continuous delivery...
von Martina Riebenbauer | Jul 24, 2020 | Automotive, Functional Safety, Medical Devices, Safety
One of the biggest challenges as a functional safety consultancy, is marrying up modern software methods and techniques with safety related requirements, and at the same time trying not to be over restrictive with the methods and processes and the advantages these can...
von 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...
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...
