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Cartiva, Inc. announced that it has received GMP (Good Manufacturing Practices) certification from Brazil's National Health Surveillance Agency (known as ANVISA). Cartiva, Inc., a private, venture capital-backed company is based in Alpharetta. The company develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions.
The certification is followed by an inspection and audit of its manufacturing facility in Alpharetta, Georgia. Brazil's GMP regulations are closely resembled with the internationally recognized ISO 13485 standards. The ISO 13485 is required to have a quality system for the design, manufacture, packaging, labeling and storage of their products from medical device manufacturers.
“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, VP 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.”
