This short video provides an overview of Agile methods and an in-depth discussion of the practical considerations for satisfying regulatory requirements.
A panel of three medical device professionals, with decades of experience across dozens of medical device companies, provide an in-depth overview of the practical realities of adopting Agile methods for medical device software development. It’s a candid discussion of the benefits and real-life challenges of implementing Agile in a heavily regulated industry.
The panelists offer an informed perspective from working in the trenches navigating the real challenges of Agile adoption. They provide an expert understanding of FDA regulations and the IEC 62304 standard.
Pingback: Newsletter V. 2019 Issue 1 - Sunstone Pilot, Inc.
Pingback: Agile Design Controls Part 3: Paperless V&V to Support Rapid Design Iterations of Medical Devices - Sunstone Pilot, Inc.