Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed. Because of this, a medical device quality system often gets pushed to the back burner in favor of activities that are perceived to add more value and meaning to the startup.
Ignoring a quality system entirely until after development is complete and the product is launched is not a good idea.
A medical device startup should treat the development of a quality management system in a similar fashion as the development of a medical device. Learn how to build your medical device quality system as you go.