SoftComply
What is FMEA?
FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all…
SoftComply
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…
SoftComply
The Importance of IEC 62304 Compliance Part 2
Following up on our first blog post on how to become a trusted software supplier to…
SoftComply
Don’t be a ”victim” of your Quality System, but instead use it to achieve your objectives!
“If you can’t beat them, join them!” If your company has decided to enter the medical…
SoftComply
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…
SoftComply
Risk Management for JIRA. Why?
Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical…
SoftComply
FME(C)A or FMEA?
FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The…
SoftComply
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…
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…
SoftComply
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe…
SoftComply
What is FMEA and when to use RPN?
Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis…
SoftComply
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…