Our facility is in compliance with FDA 21 CFR part 820 requirements. REVOX® is ISO 13485 certified sterilization facility. We utilize ANSI / AAMI / ISO 14937: 2009 and ISO 11737-1: 2006 - 2: 2009 sterilization methods that are in compliance with the FDA. With more than 35 years of excellence in regulatory compliance, we adhere to the highest quality and regulatory standards, giving you peace of mind.
As part of sterilization process development, we welcome on-site audits by our customers to foster their understanding of our commitment to regulatory compliance and adherence to high quality standards.