Over the years LSO has worked with numerous start-ups – visionaries with innovative products and good business sense, but lacking knowledge on the intense amount of regulatory policies and procedures involved in manufacturing and getting [...]
There has been an increase in the number of start-up med device companies joining, or being founded in conjunction with, Incubators. Medical Device Incubators have traditionally catered more to the business plan development or product research/design aspects of the business. And in most cases these incubators require an equity stake in the company in return for their services
Implementing a CAPA system is required by the FDA for Medical Device Manufacturing companies selling equipment within the US.