Seeking certification to ISO 9001 and/or 13485 is not a requirement, but highly preferred by our customers. Both Mesa sites made the choice to achieve ISO certification, and we pay a registrar to verify our continued compliance with these regulations. ISO 9001 is not specific to medical devices but primarily for the Quality System. ISO 13485 is almost identical except that it is more detailed for medical devices. Omaha is certified to ISO 13485, and Bozeman has both ISO 13485 and ISO 9001.