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: Risk management
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 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 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...
The recipe for agile medical device teams
Agile medical device teams used to be rare. Back in 2011, venture capitalist Marc Andreessen declared, “software is eating the world,” setting forth a then-radical idea...
How Product Managers and Development Teams Can Work In Synch when Connecting Requirements to Stories
Following previous posts on the Radbee blog about traceability matrices and release documentation, we were asked to provide details about how to create traceable...
The Essential Guide to Live vs. Static Jira Data
Lists of Jira data are crucial aspects of your team's workflow to keep your progress on track and your results quantifiable. From keeping projects progressing on time...
Digital health company? Here is your guide for risk management using Jira cloud
For a digital health company, risk management is one of the cornerstones of compliance. If you're already using Jira for other design activities, from user requirements...
Survey says: Proactive quality risk management for life science companies is a must
Klavs Esbjerg, CEO and founder of Epista Life Science, is on a mission to help his clients continuously improve regulatory compliance and in turn, transform their...
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