SoftComply
What are the best Risk Management Apps on Jira & how they compare to each other?
In the following post we compare the features of 4 top risk management apps on Jira…
How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study
“If you are developing medical device software and need to go through the certification process, look…
SoftComply
How to Secure your Documents in Confluence?
This short post will provide you insight into taking control over your document management in Confluence…
SoftComply
IEC 60601 – Essential Performance, Safety and Risk Management
IEC 60601 is a series of technical standards for the safety and essential performance of medical…
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
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 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…
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
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…
SoftComply
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…