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. Mr. Bunnewith has an extensive background in the medical device industry, having previously held key quality management positions at Creganna Medical, TE Connectivity Ltd., CR Bard, and Boston Scientific.
The ISO 13485 standard was developed by the International Organization for Standardization (ISO) and is primarily based on the general standard for quality management known as ISO 9001. However, unlike ISO 9001, ISO 13485 was specifically designed for the medical industry and requires a defined approach to risk assessment and the management of each process necessary for the development and realization of regulated medical products. Companies that comply with these quality requirements must prove that they consistently review and validate their product development and manufacturing processes, manage their operations with effective procedures, and maintain records for product traceability.
“Receiving certification to this important quality standard shows that we’re executing on the fundamental company-building initiatives necessary to obtain regulatory approval and ultimately successfully field commercial products,” said Grayson Allen, CFO/COO of RevBio. “This is a major milestone in the development of RevBio and its platform of regenerative bone repair products.”
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