SoftComply
How to Add Page Numbers to the PDF Exports of Quality Records in Confluence
Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…).…
Medical Device Compliance & Atlassian Cloud
On the 16th of October 2020, Atlassian announced radical changes to their offering. From February 2nd…
How We Managed the Compliance of Personal Protective Equipment
The Regulatory Compliance Journey of XRGO Nathaniel Victor, CEO of XRGO: “We got involved in PPE…
SoftComply
How to Use Confluence Pages as Templates
Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows…
How Cibiltech became FDA 21 CFR 11 Compliant on Atlassian Confluence
Customer Story on the MediCompli Solution at Cibiltech NOTE: Cibiltech has now successfully migrated from Atlassian…
SoftComply
Why Decompose the Probability of Harm in two – P1 and P2
P1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019…
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 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…