RevBio Receives ISO 13485 Certification for its Quality Management System

RevBio, Inc., announced that it has received ISO 13485 certification for its quality management system. Receiving ISO 13485 certification indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical products. “Having built my career in quality management over the last 35 years, I have been through over 25 ISO 13485 audits and many FDA audits,” said Gary Bunnewith, RevBio’s Director of Quality. “None have been as exciting as developing a quality management system from the ground up, navigating all the unique regulatory requirements for RevBio’s unique biomaterials platform, and receiving certification as a result of our first audit.” As one of RevBio’s first employees, Gary Bunnewith developed the quality management system and led the audit on behalf of the company. Read more >>