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On May 20th,\u00a0BeanStock\u00a0Ventures<\/span><\/a>\u00a0brought together a panel of medical device software experts, including\u00a0Jama Software<\/span><\/a><\/span><\/span><\/span>\u00a0VP of Customer Success, Clay Moore,<\/span><\/span><\/span> to bridge the gaps between modern software development and regulatory requirements.<\/p>\n The topic:\u00a0<\/span><\/span><\/span>A<\/span><\/span><\/span>gile<\/span><\/span><\/span>\u00a0development<\/span><\/span><\/span>.<\/span><\/span><\/span>\u00a0<\/span><\/span><\/span>The panel explored if Agile could\u00a0<\/span><\/span><\/span>maintain its adaptive nature\u00a0<\/span><\/span><\/span>and<\/span><\/span><\/span>\u00a0still being complaint\u00a0<\/span><\/span><\/span>under<\/span><\/span><\/span>\u00a0guidance provided by TIR45, a recognized consensus standard by the FDA.\u00a0<\/span><\/span><\/span><\/p>\n During the\u00a0webinar, the panel\u00a0de-mystifies the\u00a0idea\u00a0that Agile development lacks the proper controls for producing safe and effective software and that the regulation is burdensome.\u00a0They cover a range of exciting topics along the way.<\/p>\n <\/p>\n -Kelly\u00a0Weyrauch, Owner, Agile Quality Systems<\/p>\n –\u00a0Kelly\u00a0Weyrauch, Owner, Agile Quality Systems<\/p>\n \u2013\u00a0Kelly\u00a0Weyrauch, Owner, Agile Quality Systems<\/p>\nThe\u00a0panel explores\u00a0key\u00a0issues\u00a0about Agile and TIR45,\u00a0including:<\/h4>\n
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\nThe panel also offers insights to topical Agile questions like:<\/strong><\/h4>\nHow does one balance employing Agile methodology alongside predicting project timing\u00a0accuracy?<\/strong><\/h6>\n
“Perhaps predictability isn\u2019t the right word. A better word might be adaptability, that we can\u00a0\u00a0respond to changes in a healthy way that still meets the business needs to be predictable.”<\/em><\/strong><\/span><\/h6>\n
\nDoes\u00a0Agile help\u00a0you\u00a0tame change?<\/strong><\/h6>\n\u201cDon\u2019t try to tame change. Embrace it as a natural thing of doing product development in today\u2019s rapidly changing world. And Agile provides mechanisms to be in control of those\u00a0changes.\u201d<\/strong><\/em><\/span><\/h6>\n
\nWhat\u2019s the right level of regulatory burden?
\n<\/strong><\/h6>\n\u201cIt is generally not the regulations that bring the burden. It\u2019s an organization\u2019s interpretation of them. And nearly every case when I see an organization saying they have a burdensome process, it\u2019s 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\u2019s burdensome.”<\/em><\/strong><\/span><\/h6>\n
\nS<\/span>o much more was covered in this informative session.\u00a0<\/span>To s<\/span>ee what you missed<\/span>, h<\/span>ead over and watch the\u00a0<\/span>on-demand\u00a0<\/span>webinar now.<\/span><\/h5>\n