by Rina Nir | Dec 28, 2021 | Agile, Atlassian Cloud, Electronic QMS, Jira Cloud, Jira Service Management
There is nothing like that buzz of starting a new project. It’s early days, and our small team is getting the ball rolling. We have a clinical App to build, the Heart-Health App (temporary name), which will help people with managing cardiac problems. We plan to... 
by Rina Nir | Sep 28, 2021 | Atlassian Cloud, Confluence, Electronic QMS, how-confluence-meets-the-needs-of-document-users, Jira Snapshots for Confluence
Design reviews are an integral part of managing a development project, as per the regulatory requirements of IEC 62304. Not only must each specification item be reviewed (i.e., a user need, a functional specification), but design review documentation needs to exist as... 
by Rina Nir | Sep 16, 2021 | Atlassian Cloud, Confluence, Electronic QMS, JIRA, Risk management
Following previous posts on the Radbee blog about traceability matrices and release documentation, we were asked to provide details about how to create traceable release items (i.e. Connecting Requirements to Stories). Specifically, readers wanted to know how a user... 
by Rina Nir | Sep 8, 2021 | Atlassian Cloud, Confluence, Jira Snapshots for Confluence, Risk management
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 and on budget to acing audits, your Jira data holds the key to business growth. That said,... 
by Rina Nir | Sep 1, 2021 | Atlassian Cloud, Confluence, Electronic QMS, Jira Snapshots for Confluence
Jira is where your development happens, period. As time passes, your Jira use expands, and along with it, your issue types list. At first, it’s stories, bugs and tasks. Later, product risks, requirements, test cases, and test runs are added. To get the real... 
by Rina Nir | Aug 20, 2021 | Atlassian Cloud, Confluence, Electronic QMS, Jira Snapshots for Confluence
If your team is working on a Software as a Medical Device (SaMD), you’ll probably choose an Agile approach. Running sprints, computing velocity, grooming, retrospectives — all of that lingo becomes part of your culture. But just because the word...