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Consultant Richard Koch on combining IEC 62304 with Agile on Jira
Richard Koch has a rare expertise: he guides teams in transforming clinical data into medical products and develops his own medical device software. Based in Switzerland, Richard is at the heart of one of the largest MedTech hubs. His methods are fresh and at the innovation forefront. He aims to combine regulatory standards with Agile principles. IEC 62304 is the main reference for his work as it specifies the processes governing the development of software in medical devices. Many of his customers are companies in the SaMD (Software as a Medical Device) area. These are software developers making Apps that fall under the legal definition of...
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Love linking issues in Jira but can’t see the big picture?
On the face of it, Jira has only two or three levels of hierarchy. Standard issue types as parents and sub-task issue types as children are the two levels. Epics sort...
Agile in Pharma? Let DevOps charge your Agile transformation
Pharmaceutical companies are in a hurry to adopt agile software development practices. It's a massive trend seeing companies forcing teams to climb the agile train....
How to efficiently manage your suppliers list by integrating Jira with Confluence
We manage a process in Jira and need to share the results of the process with a wider audience, how can we do this in an inclusive manner? By inclusive, I mean- with...
Managing requirements in Jira? Here is how to shape up your medical device risk management process
Using Jira for requirements management? Extending this to managing medical device risks is the logical next step. There is a complete article about how to configure the...
No data creep – The snappiest way to Jira reports just turned into a zero data risk app.
Yes, we mean what you think it means. As of May 2022, Jira Snapshots for Confluence stores all your data inside the Atlassian infrastructure. Zero data risk means that...
How to use Confluence to resuscitate your sprint reviews?
We created Sprint reviews so that we can all come together. The product owners, the marketing team, the customer success team, and the developers. Developers share...
How Jira reports in Confluence has made one IT team shine
Since Cross Land Logistics (imaginary company) upgraded its internal IT service into Jira Service Management, the IT team had the wind in their back. With Jira reports...
How to use Confluence to churn out product release documents that dazzle
We completed the configuration project. The team now had an Atlassian site that helped them develop their medical device quicker, along with all the required release...
How Confluence API powers the release flow of a SaMD product
This is a real story about a SaMD company (Software as a Medical Device) that wanted to achieve high release cadence. They hired us to develop a custom Confluence...
RadBee is now driving success for Monday.com users
We're pleased to announce that RadBee is a certified partner of Monday.com Monday.com Work OS is the platform built for a new way of working, adopted already by more...
How We Leveraged Jira API To Calculate Requirements Traceability Status
One of the not-so-secret powers of Jira is its extensibility. Despite the power of its features, we cannot solve all use cases by configuration or by installing a...
How to Create Software Requirements Baseline from Jira?
Many Application Lifecycle Management (ALM) tools have a baseline feature that can be used for defining Software Requirements Baseline. Jira out of the box does not...