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UPDATE: This webinar has now happened. We will be releasing content from it in the coming weeks.

Medical device software and product teams are increasingly looking to Agile solutions to help increase quality through more regular feedback loops. The advice of AAMI TIR45 has further advanced this approach, which provides clear guidance as to how an Agile approach can work when trying to achieve IEC 62304. However, there is a hidden cost to effectiveness and efficiency that TIR45 glosses over. While it gains a considerable increase in quality with early and regular feedback loops, there is an increased burden of additional testing needed at every stage.

This increased burden can make software teams start to question whether Agile and medical devices are compatible, with release cycles stretching out beyond expectation. So, teams get stuck with an impossible puzzle; accept longer release times or, worst case, sacrifice quality.

But what if things didn’t have to be this way?

How can you cut down release cycles in medical device projects while ensuring compliance and without sacrificing quality? How do you ensure that TIR45 works with you and not against you?

Make TIR45 work for you

Taking a software focus, our upcoming webinar shows how practices like test automation and living documentation can cut down release times for medical device product teams following Agile practices and applying TIR45 guidance. We will also demonstrate how living documentation and test automation support innovation, maintain quality and enable compliance.

Working in partnership with Pharma iQ and hosted by Paul Massey, Bluefruit Software’s Founder and Director, our interactive session will show how to mature Agile practices for medical devices.

What can you expect?

We’ve written before about how processes from Lean-Agile software development can help improve the effectiveness of software and product development while cutting waste and improving quality. On the blog, we’ve also looked at how Lean-Agile is an excellent fit for medical device development.

This session “How to achieve shorter release cycles for medical devices” complements our Lean-Agile series and delves directly into Bluefruit Software’s experience in bringing test automation and living documentation to projects.

While we will be touching on subjects like Test-Driven Development (TDD) and Behaviour-Driven Development (BDD), as well as Lean-Agile, the core part of the event covers living documentation and test automation.

Looking at client medical device case studies (including a device that has just achieved FDA and CE approval) and Bluefruit’s R&D work applying AI (neural networks), Paul’s session will examine:

  • The benefits of shorter release cycles for software on medical devices.
  • Implementing test-automation setups as a part of your development activity.
  • Using both living documentation and test automation to follow AAMI TIR45 successfully.
  • How test automation stops TIR45 from becoming a burden on teams.
  • How living documentation reduces the documentation load that comes with shorter release cycles.
  • … And more.

NOTE: This webinar has happened. We will be releasing materials based on it in the coming weeks.

Want to read up on Lean-Agile, TDD and BDD ahead of the webinar?

If you’d like to know more about the processes and practices that we use every day working alongside our clients, you should check out these articles.