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...
Consultant Richard Koch on combining IEC 62304 with Agile on Jira
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Posts about: Electronic QMS
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....
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 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...
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...
The Calm Way To Export Jira Data To Confluence And Build Clients Trust
Project managers are often pulled in two separate directions by the people they serve: their team and clients. Developers want to protect their autonomy, while clients...
The juggle-free way to sign controlled documents on Confluence Cloud
Confluence Cloud was their knowledge hub. So it was practical to move the Standard Operating Procedure (SOPs) and other controlled documents to Confluence Cloud too....
How RadBee can help setting your QMS on Jira and Confluence.
Building a QMS on Jira and Confluence makes sense, especially if your team already uses this platform. You may find it complicated and grueling to do it solo, so you...
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