Documenting compliance with IEC 62304 in medical device software development

Ever had problems with compliance to IEC 62304? Do you want to apply Agile development principles such as SCRUM when working with medical device software? No problem! In this video, Christian Kaestner will explain how you can work the way you want and document how it is compliant with IEC 62304. If you are into Agile development, you will also get a teaser from AAMI TIR 45, which is about “Guidance on the use of AGILE practices in the development of medical device software”. This is an excerpt from the course "Introduction to Software for Medical Devices and IEC 62304" which is available at: https://medicaldevicehq.com/iec62304 Read more about documenting compliance with IEC 62304 and working with Agile here: https://medicaldevicehq.com/iec-62304-medical-device-software-development-compliance/ Don't miss checking out the online course Introduction to SaMD and IEC 82304-1: https://medicaldevicehq.com/introduction-to-samd-iec62304-and-iec-82304-1-online-course/ Chapters: 0:00 Introduction 0:23 About the instructor 0:40 Meeting the requirements of IEC 62304 1:25 Compliance checklist 2:25 Software development processes 5:04 Different development methods 5:52 Standard requirements 6:45 Verification of requirements of the standard 7:46 Scrum and waterfall 9:53 AAMI technical report 11:48 Additional resources