Embracing Change: Your Connected Medical Device is Never Finished
Embracing change means setting up your organization, processes, and tools to efficiently manage changes during product development and after product launch.
Agile Design Controls: Dynamic Risk Management for SW-Intensive Medical Devices
Learn the nuts and bolts of how to integrate risk management into the overall product development workflow using a requirements management SW tool to create a more flexible and rigorous approach than standalone spreadsheet methods.
Recording of Agile Design Controls Part 1 Available
If you missed the Agile Design Controls Webinar Part 1, here is a recording of it.
For background on the bigger picture of applying agile methods to medical device development, take a look at this webinar: “Why Haven’t More Medical Device Companies Embraced Agile?”
Additional Resources
- Ever wonder what it would look like if you mapped out all the DHF documents for a typical medical device and their interdependencies? Take a look at this “map” of documents and their relation to a 510(k) submission Medical Device Documentation Map
- Great article about Medical device software testing