Watch it now: TIR45 | An AGILE Approach to Software Regulatory Requirements

May 27, 2020 Jama Software


On May 20th, BeanStock Ventures brought together a panel of medical device software experts, including Jama Software VP of Customer Success, Clay Moore, to bridge the gaps between modern software development and regulatory requirements.

The topic: Agile development. The panel explored if Agile could maintain its adaptive nature and still being complaint under guidance provided by TIR45, a recognized consensus standard by the FDA. 

During the webinar, the panel de-mystifies the idea that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome. They cover a range of exciting topics along the way.

The panel explores key issues about Agile and TIR45, including:

  • How the Agile Manifesto is trying to encourage us to find the proper balance – not get rid of the discipline and documentation that we need, but to find a better balance between that and developing useful working products. 
  • How the development of a foundation of requirements is the single most important design control activity because requirements which form the design input establish the basis for performing tasks and validation of design.
  • How TIR45 helps address common misconceptions about applying Agile at scale with multiple teams, and the need for documentation. 

The panel also offers insights to topical Agile questions like:


How does one balance employing Agile methodology alongside predicting project timing accuracy?
“Perhaps predictability isn’t the right word. A better word might be adaptability, that we can  respond to changes in a healthy way that still meets the business needs to be predictable.”

-Kelly Weyrauch, Owner, Agile Quality Systems

Does Agile help you tame change?
“Don’t try to tame change. Embrace it as a natural thing of doing product development in today’s rapidly changing world. And Agile provides mechanisms to be in control of those changes.”

– Kelly Weyrauch, Owner, Agile Quality Systems

What’s the right level of regulatory burden?
“It is generally not the regulations that bring the burden. It’s an organization’s interpretation of them. And nearly every case when I see an organization saying they have a burdensome process, it’s because they did it to themselves. They defined their process, they defined the documentation requirements, they defined the sequencing of things and the rules behind it, in a way that’s burdensome.”

– Kelly Weyrauch, Owner, Agile Quality Systems

o much more was covered in this informative session. To see what you missed, head over and watch the on-demand webinar now.




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