What is FMEA?
FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all…
Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!
We are happy to inform you that our Risk Management solution for Jira has gotten an…
What is a Risk Mitigation Requirement and How to Write It?
Medical device risk mitigation actions aim at reducing the occurrence and/or the severity of the potential…
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…
Risk Management for JIRA. Why?
Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical…
FME(C)A or FMEA?
FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The…
What is a Risk/Benefit Analysis & How To Do It?
The Risk / Benefit analysis is one of the most misinterpreted areas of the Risk Management…
Blog-Bolt
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…
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe…
What is FMEA and when to use RPN?
Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis…
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…
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…