2021-10-25 Rina Nir: How medtech companies can use Jira & Confluence for managing requirements and release documentation
This is the 64th of our Monday Night Specials, a series of virtual events with voices from the Atlassian ecosystem.
Bevy: https://ace.atlassian.com/e/m5gkw5/
Meetup: Requirements and release documentation with Atlassian in medtech companies | Meetup
Community Post: RSVP: Rina Nir, RadBee, about Requirements & Relea... - Atlassian Community
Slides:
Presenter: Rina Nir
Rina is the CEO of RadBee Ltd. As an Atlassian Solution Partner, RadBee helps medtech and pharma companies leverage the Atlassian tools to achieve regulatory compliance and operational efficiencies. We come from this industry and have experienced first-hand the sweat and pain that goes into Quality and Regulatory compliance. We cannot make the regulatory beast go away, but we surely know how to tame it.
Prior to starting RadBee, Rina co-founded a medical devices company and lead its R&D, operations and HR functions. In this role she was involved in the implementation of an ISO 13485 quality system and making submissions to the regulatory authorities in Europe and the United States. This gave her firsthand experience of the challenges of balancing innovation and compliance in life sciences operations and how JIRA can help.
She went on to establish RadBee, inspired by her conviction about the key role Atlassian tools can play in modernising R&D and quality processes.
Rina regularly writes and presents about issues related to compliance and how JIRA and Confluence can help.
Rina is an Israeli and is a software engineer by trade. Currently she lives in Cambridge, The United Kingdom.
How medtech companies can use Jira & Confluence for managing requirements and release documentation
Digital health and other MedTech teams who want to adopt modern practices like Agile and DevOps, find themselves in a particularly tough spot. They need to do so while still satisfying the requirement of the regulatory authorities. These teams are so consumed with meeting regulatory requirements that a whopping one-third of their operational budget goes into “Quality Assurance and Compliance”- and not only is compliance a direct expense, it also has the impact of slowing down your release cadence. While modern software companies may be releasing multiple times a day, most of the medtech industry still releases only a few versions every year.
In an illuminating presentation, Rina will share insider tips and stories on how MedTech teams can find their unique flavor of Agile and DevOps, and how they can harness the power of Jira & Confluence to make this work for them: Think of frequently releasing medical device software and keeping it safe & compliant.
We’ll discuss:
What are the particular challenges related to adopting Agile and DevOps in a regulated environment?
What does a holistic DevOps/Agile approach look like, so that it also covers the regulatory requirements? In particular- how to work Agile and DevOps so that release documentation is created as part of your daily process and traceability matrices are generated “on the fly”.
How to implement this DevOps/Agile approach using Jira and Confluence. This part will include a live demo
From the fundamentals to precise tooling and real-life examples, you’ll gain invaluable insight into how to automate QA and ensure compliance. With less waste and a more streamlined process, your team will be freed up to focus on what matters most: delivering quality products that support better outcomes for all.
The teachings provided are mostly true for teams in other heavily regulated industries like automotive, environmental sciences, and banking. Each industry has its own terminology, but the critical need to efficiently manage releases and traceability matrices is universal.
About RadBee
RadBee is an atlassian solution partner and marketplace vendor, who specializes in serving the medtech and pharmaceutical industry..
Your work saves lives. Ours saves your sanity.
Digital workflows are just the starting point for an effective eQMS evolution. RadBee is your partner in innovative, waste-cutting systems that deliver quality to the delight of your team, auditors and customers. We understand your challenges because we’ve been there, and we have the foresight to spot problems before you do. You can count on us to go the extra mile — so you don’t have to.
RadBees website: https://www.radbee.com/
Rina’s Linkedin profile: https://www.linkedin.com/in/rinanir/
On Atlassian marketplace: Jira Snapshots for Confluence: https://marketplace.atlassian.com/apps/1225123/jira-snapshots-for-confluence
Sandbox environment: radbee-sandbox.atlassian.net
Images
Social |
|||
|---|---|---|---|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|||