Topic: medical device product development from a compliance perspective.
The outline below is very much centered on FDA / US regulations. It could fairly easily be expanded to cover 13485 and then there could be an add-on for regulations in other jurisdictions (Canada, EU, etc… and possibly covering MDSAP although this might get too deep in regulatory affairs).
Objective: basic understanding and application of the regulations driving the development efforts
- Inspiring engineering minds to advance human health