SoftComply
What is a Risk Management File?
ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that…
SoftComply
Comparison of Risk Management Apps on Jira Cloud
Following our previous post where we compared the 4 top risk management apps on Jira Server,…
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…
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 Software Tool Validation?
Modern medical device regulations are putting more and more emphasis on the management of software tools.…
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…