About 40 people joined us at CEI this Monday at the start of Arizona BioScience week for some blunt talk about Medical Device development for startups. It was a great crowd and the questions were almost as (OK, maybe more) useful as the talk.
The gist of the seminar was a look at what it really takes to develop a medical device. We talked about the FDA, ISO 13485, QMS’s and the very well-defined process that all companies must follow. We also talked a bit about transferring to manufacturing and shared some lessons learned.
You can find a PDF of the presentation here:
As always, PADT is here to help with your medical device product development, or with the development of any product.