At FlexBiosys, quality is built into our process. We operate a quality system that is ISO 9001:2015 certified and securely maintain full traceability of our manufactured goods. While we are ISO 9001:2015 certified, our quality system also maintains many aspects of ISO 13485:2016 and cGMP standards. Our products are manufactured in an ISO Class 7 certified cleanroom, to ensure an absolute level of control. At FlexBiosys we strive to pass the most stringent evaluations – our customer’s audits. Our systems have satisfied the most demanding requirements of medical device manufacturers and we welcome you to conduct your own onsite supplier audit.