Hi all, I´m a noob here so be gentle! Our institute has designed a medical device that will be incorporated into a combined ATMP. Our chemist wants to cut costs of a raw material (a coating for a tissue culture plate) and believes that if the material is made in our university lab, it can then be sent to an outside company to get a CoA and can subsequently be used in the medical device. What are we missing here - we have no ISO 13485 or any similar quality management system. Thanks for any help.