LOWELL, Massachusetts- (BUSINESS WIRE)- RevBio, Inc. declared that its quality management system has been certified to ISO 13485. ISO 13485 demonstrates a company’s ability to build robust policies and procedures for developing and producing regulated medical products.
Gary Bunnewith, RevBio’s Director of Quality, said, “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.” “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. Having previously held important quality management positions at Creganna Medical, TE Connectivity Ltd., CR Bard, and Boston Scientific, Mr. Bunnewith has a wealth of experience in the medical device business.
The International Organisation for Standardisation (ISO) created the ISO 13485 standard, based on the ISO 9001 general standard for quality management. In contrast to ISO 9001, ISO 13485 is especially designed for the medical sector and calls for a method of risk assessment and the management of every procedure required for creating and implementing regulated medical products. Businesses that meet these quality standards demonstrate that they manage their operations with efficient procedures, continuously examine and validate their manufacturing and product development processes, and keep 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.”
About RevBio, Inc.
TETRANITE® is a patented synthetic injectable biomaterial that is osteoconductive and self-setting. It develops and marks RevBio, Inc., a clinical-stage medical device firm. The company is initially developing this technology for use in the animal health industry and the dental, cranial, and general orthopaedic markets. The commercial usage of RevBio’s TETRANITE technology is now pending approval.
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