Artificial organ quality system

A start-up company developing a tissue product used in organ replacement asked for Chimera’s help in establishing a quality system that was compliant with CGMP, QSR and Good Tissue Practice requirements. Chimera worked with the QA department in structuring the quality system and drafting quality policy and procedures. Chimera also recommended that since the shipping container contained functional elements its design should also be developed under a medical device design control system.