(no title)
jdgiese | 3 years ago
I run a medical device software development firm. I'm a software engineer who has moved into the medical-device regulatory affairs. I've helped several software teams learn to develop (and document) software for medical devices.
Even if you're not planning to make the jump from a wellness app to a medical device for a while, there are some things you can start documenting now that will make the transition a lot easier for you when you get there. E.g., starting to track formal requirements (https://innolitics.com/articles/2022-04-27-design-inputs/) and tracing them to verification protocols (e.g., automated or manual tests).
We have a bunch of Notion templates that we use with our clients that I could share with you to help you get started. Feel free to email me at jdgiese AT Innolitics.com
No comments yet.