ISO Certification

As an ISO 13485:2003-certified facility, we adhere to quality management system requirements for medical devices. Our processes and controls are designed to ensure quality, safety and reliability.

Download our ISO 13485:2003 certificate of registration.

ISO Class 7 Clean Room

TissueGen manufactures and develops ELUTE fiber in an ISO Class 7 cleanroom environment to support compliance with the Food and Drug Administration’s cGMP regulations for manufacturing drug product.