Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced that it has received GMP (Good Manufacturing Practices) certificaton from Brazil's National Health Surveillance Agency (known as ANVISA) following an inspection and audit of its manufacturing facility in Alpharetta, Georgia. Brazil's GMP regulations, which closely resemble the internationally recognized ISO 13485 standard, require medical device manufacturers to have a quality system for the design, manufacture, packaging, labeling and storage of their products.
"We are pleased with the successful completion of the ANVISA inspection and GMP certification, which is evidence of our commitment to produce innovative products in strict adherence to our quality system," said Deborah Moore, vice president of regulatory, clinical and quality affairs of Cartiva, Inc. "Validation from ANVISA, whose rigorous regulatory standards are similar to those in the United States, represents an important milestone on the path to commercialization of Cartiva."
Peter Pizzo, 770-754-3855
Chief Financial Officer