What is FMEA and how is it different from Hazard Analysis?
From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question “What happens if … ?”. Components are analysed one at a time, thus generally looking at a single-fault condition. This is done in a “bottom-up” mode, […]
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]
What is FMEA and when to use RPN?
Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA) are techniques by which an effect or consequences of individual components are systematically identified and is more appropriate as the design matures.“ We won’t go into the details of the FMEA, but often we were asked to explain when (and […]
How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA
Part II By Matteo Gubellini, VP of Regulatory Affairs at SoftComply* So you are looking for a Risk Management tool? Something easy to use, with good traceability features? There is plenty out in the market to pick from. All of them good tools, that tick all the boxes. I have been there several times, both […]
How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA
Part I By Matteo Gubellini, VP of Regulatory Affairs of SoftComply* “Ok, let’s follow a few of these risk mitigation actions down to outputs and verification activities” says the auditor. Typical question. Actually there couldn’t be a more typical audit question. Traceability. We have been here dozens of times. And every time it’s the same […]
