The documentation needed for medical device software is lengthy and complex. This article provides a list of needed documentation and tips on the best way to manage it.
Erik Heuer describes his experiences accelerating medical device software development by bridging the gap between regulatory compliance and modern software development methods: incorporating DevOps concepts, leveraging documentation automation, and establishing the two wheels for innovation vs. development and deployment.
April 2021 Newsletter – Better Approach to Medical Device Development Let’s Get Back to Basics Medical device development is often discussed in terms of adhering to new regulations or standards. While the complexities of good compliance are certainly important, it’s easy for teams to overlook the basics of what’s needed to successfully develop an innovative …
Proven ideas to be able to catch problems earlier in complex product development, rather than wait for the finale of a big integration. Break the large stretches of work into small micro projects. When possible, build prototypes in these micro projects and demonstrate to customers to get early feedback.