Agile in a Regulated Environment with Bernhard Kappe

from Yale Certificate in Medical Software and Medical AI: Guest Experts

Our guest is Mr. Bernhard Kappe (https://www.linkedin.com/in/bernhardkappe/) who is the founder and CEO of Orthogonal (https://orthogonal.io/), a medical device consulting company. He is also a member of the AAMI working group AAMI SW WG-10 Cloud Computing. This interview was recorded on Nov 16, 2023. Further Reading: Kappe B. Accelerating Medical Product Development: Applying Agile Methods to Shorten Timelines, Reduce Risk and Improve Quality [Internet]. Orthogonal; 2020. Available from: https://orthogonal.io/insights/agile/ebook-agile-in-an-fda-regulated-environment/ Association for the Advancement of Medical Instrumentation (AAMI). AAMI TIR45: 2023; Guidance on the use of agile practices in the development of medical device software. Arlington VA: Association for the Advancement of Medical Instrumentation; 2023. Report No.: TIR45. https://webstore.ansi.org/standards/aami/aamitir452012r2018?gad_source=1 Agile Lego Game: https://www.youtube.com/watch?v=0lA00lDs_R4 https://www.youtube.com/watch?v=7BKPDScVb5U

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This episode was published on March 19, 2024.

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