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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