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The recipe for agile medical device teams

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 that software programming tools and internet-based weren’t just catalysts for countless industries — they were here to stay. A decade later, it’s safe to say the life science industry has become nearly entirely software-driven. From personal health apps to surgical robots and AI diagnostics, software developers are joining MedTech companies in droves, bringing another culture with them. The medical device industry is going...

Two Quick and Easy Ways to Do Design Reviews for Requirement Documentation

Two Quick and Easy Ways to Do Design Reviews for Requirement Documentation

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 ‘evidence for compliance’.  Luckily, the documentation process for design reviews doesn’t have to be time-consuming or complicated. There are a couple of easy ways to get the job done. To illustrate, we’ll use a fictional product manager, Julia, and the medtech company for whom she works, SmashMed Ltd. Both the company and...

How Product Managers and Development Teams Can Work In Synch when Connecting Requirements to Stories

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 release items (i.e. Connecting Requirements to Stories). Specifically, readers wanted to know how a user requirement or a functional specification is processed and relates to development work on stories. So, in this post, we’ll dig into the details with a simple example that illustrates how traceability items connect to stories. By the time you finish reading, you’ll understand the process — and what team collaboration looks like in...

The Essential Guide to Live vs. Static Jira Data

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 and on budget to acing audits, your Jira data holds the key to business growth. That said, there are two broad types of lists you can create using Jira data: live and static. Once you’ve defined the criteria necessary to scope the list correctly, including which fields to use, you’re ready to choose which type of list you need — and the best tools for this critical task.  What’s the difference between live and static Jira data?...

The Ultimate Guide to Creating and Exporting Traceability Matrices in Jira

The Ultimate Guide to Creating and Exporting Traceability Matrices in Jira

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 picture you want to view issues not as a disconnected list but rather as an hierarchical structure; i.e. traceability matrix. Jira doesn’t make it easy or convenient to create and export traceability matrices. A large installation may easily have dozens of issue types and while these items, each have their own life cycle — from creation...

Agile Alone Doesn’t Solve SaMD (Software as Medical Device) Release Delays

Agile Alone Doesn’t Solve SaMD (Software as Medical Device) Release Delays

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 “agile” means quick and makes iteration sound like a snap, regulatory requirements can grind the process to a halt. And what often stands in the way is release documentation. Here’s how it typically plays out: The new software is implemented and tested, ready for release in the internal teams’ eyes. All that’s left is the documentation, and how long...

Document management in Confluence Cloud

Document management in Confluence Cloud

Confluence Cloud is becoming the dominant Confluence option, which means it’s increasingly important to understand how to set the platform up for document management. Document management is one of the cornerstones of a quality management system. This typically involves uniquely identifying each official document, approving new versions before they become effective, removing obsolete versions, as well as some other good-governance factors. In medtech and pharma, this is also called the “controlled documents process.”  In this post, I’ll be focusing on how to get your Confluence pages...

How iText Put the PDF in Our Speedy PDF App

How iText Put the PDF in Our Speedy PDF App

When we conceived Speedy PDF Sign-Offs For Jira Cloud, we had one overarching mission: to help fast-moving teams quickly capture and archive electronic signatures and document issue resolution and approvals in a well-designed, compliant PDF. This is the story on how we ended up choosing  iText  to enable all that. Notice our priorities: Speed Smooth workflow Compliance Well-designed and easily archivable PDF Simple, right? Not so much, given the stringent parameters our clients require — particularly those in the heavily regulated life sciences industry. When paper sign-offs for regulatory...

How to integrate your automated tests pipeline with Jira and Xray?

How to integrate your automated tests pipeline with Jira and Xray?

Let's say that you are committed to automated tests and have also built a fluent CI (Continuous Integration) pipeline. Each commit triggers the pipeline and runs a set of automated tests. However, your development cycle starts in Jira, and you would like to close the loop in Jira too. Hence, you want that the automated test cycles will be reported into Jira, providing greater visibility into the status of development. Moreover, in situations where evidence of successful testing is required; i.e. from compliance reasons, it would be easier to tie all the traceability together if test results...

Using EazyBI to report Jira Service Management SLAs

Using EazyBI to report Jira Service Management SLAs

At RadBee, we’re able to help many of our clients who are using Jira Service Management to better use EazyBI for monitoring the performance of their customer service teams and generate specific and targeted reports toward that goal. This story is the product of an exceptionally complicated client support situation. We found ourselves closely interacting with EazyBI’s fantastic support team, in order to configure specific data import capabilities into EazyBI. You’re welcome to use the logic and code provided at the end, if you face a similar situation.   Applicable scenario: Service calls are...