What stage is your business in?
During this phase, you're focused on developing your product. You should also be thinking about usability studies, risk assessments and establishing your Quality Management System.
You're busy wrapping up your design. But now, you're also tasked with performing safety testing and human factors, software and system validation to ensure your device is ready to go to market.
It's finally time to pull together your submission. This means getting all your documentation in order and preparing communications with the FDA or notified body.
Congratulations for making it to this point. You're now addressing complaints, CAPAs, warning letters revisions to your product. And, when you're ready, you'll be considering expansion into new markets.