What is Probability of Failure of Medical Device Software?
One of the more controversial requirements of IEC 62304 is the probability of failure of medical device software during Risk Analysis. EN 62304:2006 paragraph 4.3 “Software Safety Classification” states “If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the probability of such failure shall be assumed to be […]
Risk Management for JIRA. Why?
Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical domains. It is a specific aspect of safety-critical system development that requires linking risks to system/software design and testing to ensure the system is safe to use. Various standalone solutions exist today for safety-critical system developers that help automate […]
FME(C)A or FMEA?
FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The answer is simple: it depends. You are probably fed up with the “it depends” answers you get in this sector. But in this case it means “It depends on YOU”. First the compliance bit: there is no requirement, in […]
What is a Risk/Benefit Analysis & How To Do It?
Introduction The Benefit-Risk analysis is one of the most misinterpreted areas of the Risk Management process. And consequently one of the preferred digging points for the Notified Bodies. The spirit of the regulations and standards is “the benefit provided by the use of the device must outweigh the associated risk”. That sounds simple doesn’t it? […]
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 […]
